**[ATTACHMENT A]{.underline}**

**[CLASS I DEVICES EXEMPT FROM MOST OF THE QS/GMP REQUIREMENTS BY
CLASSIFICATION REGULATIONS]{.underline}**

THE FOLLOWING LIST OF EXEMPTED CLASS I DEVICES IS ARRANGED IN PRODUCT
CODE SEQUENCE.

TO USE THIS LIST CONSULT THE KEY WORD LIST FOR DEVICES TO DETERMINE THE
PRODUCT CODE. THE KEY WORD LIST WAS FORMERLY INCLUDED IN THE
[EDRO]{.underline} [DATA]{.underline} [CODES]{.underline}
[MANUAL]{.underline} (TN-84-1) AND WILL BE ON FILE IN THE DISTRICT\'S
REFERENCE FILE.

**ANESTHESIOLOGY DEVICES**

(Final Regulation Published in July 16, 1982 [FEDERAL]{.underline}
[REGISTER]{.underline};

EFFECTIVE DATE: 8/16/82)

[REGULATION]{.underline}

73 BTB HOOK, ETHER 868.5420

73 BXJ CLIP, NOSE 868.6225

73 BXL ALGESIMETER, MANUAL 868.1030

73 BYN CHAIR, POSTURE, FOR CARDIAC 868.5365

73 BYO BOTTLE, BLOW 868.5220

73 BYW REBREATHING DEVICE 868.5675

73 BZN CART, EMERGENCY, CARDIOPULMONARY 868.6175

73 CBG SPREADER, CUFF 868.5760

77 EPE BRUSH, CLEANING, TRACHEAL TUBE 868.5795

73 JFE VALVE, SWITCHING (PLOSS) 868.1965

**CARDIOVASCULAR**

74 ‑‑‑ (No devices have been exempted)

**CLINICAL CHEMISTRY DEVICES**

(Final Regulation Published in May 1, 1987 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 7/30/87)

75 JBS TIMER, GENERAL LABORATORY 862.2050

75 JJP ION SELECTIVE ELECTRODES (NON‑SPECIFIED) 862.2050

75 JQO ANALYTICAL BALANCE 862.2050

75 JQQ DIALYZER 862.2050

75 JQY PH METER 862.2050\
75 JQZ POLARIMETER 862.2050

75 JRB MICRO MIXER 862.2050

75 JRG HEATING BLOCK 862.2050

75 JRJ DRYING UNIT 862.2050

75 JRK EVAPORATOR 862.2050

75 JRL MEMBRANE FILTER UNIT 862.2050

75 JRM FREEZER 862.2050

75 JRO BLENDER/MIXER 862.2050

75 JRQ SHAKER/STIRRER 862.2050

75 JRR TEMPERATURE REGULATOR 862.2050

**DENTAL DEVICES**

(Final Regulation Published in August 12, 1987 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 9/11/87)

76 EBH MATERIAL IMPRESSION TRAY RESIN 872.3670

76 EEA BASE PLATE SHELLAC 872.6200

76 EEJ GUARD, DISK 872.6010

76 EFH PAPER, ARTICULATION 872.6140

76 EFW TOOTH BRUSH, MANUAL 872.6855

76 EFX PROTECTOR, SILICATE 872.6670

76 EGD INTRAORAL DENTAL WAX 872.6890

76 EGZ FILM, X‑RAY HOLDER 872.1905

76 EHJ DISK, ABRASIVE 872.6010

76 EHK PROPHYLAXIS CUP 872.6290

76 EHL POINT, ABRASIVE 872.6010

76 EHM STRIP, POLISHING AGENT 872.6010

76 EHY TRAY, IMPRESSION, PREFORMED 872.6880

76 EIE DAM, RUBBER AND ACCESSORIES 872.6300

76 EJP ARTICULATOR 872.3150

76 EJQ WHEEL, POLISHING AGENT 872.6010

76 JET PICK, MASSAGING 872.6650

76 KCO TUBE IMPRESSION AND MATRIX 872.5220

76 KCR FACE BOW 872.3220

76 KCS PANTOGRAPH 872.3730

76 KHR SALIVA ABSORBER PAPER 872.6050

76 KMT DISPOSABLE FLUORIDE TRAY 872.6870

76 KXR RESIN APPLICATOR 872.4565

**EAR, NOSE, AND THROAT DEVICES**

(Final Regulation Published in November 6, 1986 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 12/8/86)

77 ESE LARYNX, ARTIFICIAL (BATTERY‑POWERED) 874.3375

77 ETM GUSTOMETER 874.1500

77 JPN MANUAL NEBULIZER PUMP 874.5220

77 JXS BLOCK, CUTTING, ENT 874.3540

77 JXT CRIMPER, WIRE, ENT 874.3540

77 JXW DIE, WIRE BENDING, ENT 874.3540

77 JXX FORCEPS WIRE CLOSURE, ENT 874.3540

77 JXY JIG, PISTON CUTTING, ENT 874.3540

77 JXZ PUNCH, GELFOAM 874.3540

77 JYA SCISSORS, WIRE CUTTING, ENT 874.3540

77 JYB VISE, OSSICULAR FINGER 874.3540

77 KCL BLOWER, POWDER, ENT 874.5220

77 KCM DROPPER, ENT 874.5220

77 KCN EAR WICK 874.5220

77 KCO INHALER, NASAL 874.5220

**GASTROENTEROLOGY‑UROLOGY DEVICES**

(Final Regulation Published in November 23, 1983 [Federal]{.underline}
[Register]{.underline};

EFFECTIVE DATE: 12/23/83)

78 EXI PASTE‑ON DEVICE FOR INCONTINENCE 876.5250

78 EXJ DEVICE, INCONTINENCE, UROSHEATH TYPE 876.5250

78 EXN HERNIA SUPPORT 876.5970

78 EYQ PROTECTIVE GARMENT FOR INCONTINENCE 876.5920

78 EYT SHEATH, CORRUGATED RUBBER 876.5250

78 FAQ BAG, LEG (FOR EXTERNAL USE) 876.5250

78 FCE ENEMA KIT 876.5210

78 FFH COLLECTOR, URINE, PEDIATRIC 876.5250

78 KNX URINE COLLECTOR AND ACCESSORIES 876.5250

([not intended to be connected to an]{.underline}

[indwelling catheter:]{.underline}

**GENERAL AND PLASTIC SURGERY DEVICES**

79 KCZ PROSTHESIS, BREAST, EXTERNAL 878.3800

**GENERAL HOSPITAL AND PERSONAL USE DEVICES**

(Final Regulation Published in October 21, 1980 [Federal
Register:]{.underline}

EFFECTIVE DATE: 11/20/80)

80 FLH SANITIZER, MECHANICAL 880.6800

80 FMA DEPRESSOR, TONGUE 880.6230

80 FME GOWN, EXAMINATION 880.6265

80 FMF NON‑STERILE IRRIGATING SYRINGE (SYRINGE) 880.5860

80 FMH CONTAINER, SPECIMEN 880.6175

80 FML CHAIR, BLOOD DONOR (NON‑WHEELED) 880.6140

80 FMP PROTECTOR, SKIN PRESSURE 880.6450

80 FMQ RESTRAINT PROTECTIVE 880.6760

80 FMR TRANSFER DEVICE, PATIENT, MANUAL 880.6785

80 FMW MATTRESS COVER (FOR MEDICAL PURPOSE) 880.6190

80 FNJ BED, MANUAL 880.5120

80 FNN NIPPLE, LAMBS FEEDING 880.5640

80 FNP URINAL 880.6730

80 FNS RING CUTTER 880.6200

80 FNY BASIN, EMESIS 880.6730

80 FOA BOARD, CARDIOPULMONARY 880.6080

80 FOB BEDPAN 880.6730

80 FOK PAD, NEONATAL EYE 880.6025

80 FOR NON‑STERILE ABSORBENT TIPPED APPLICATOR 880.5270

80 FPF BOTTLE, HOT/COLD WATER 880.6085

80 FPP STRETCHER, HAND CARRIED 880.6900

80 FPS BOARD, BED 880.6070

80 FQA SCALE, SURGICAL SPONGE 880.2740

80 FQJ THERAPEUTIC SCROTAL SUPPORT 880.5820

80 FQK BINDER, PERINEAL 880.5160

80 FQL STOCKING, MEDICAL SUPPORT 880.5780

80 FQM BANDAGE, ELASTIC 880.5075

80 FRI SCALE, STAND‑ON, PATIENT 880.2700

80 FRJ CHAIR, GERIATRIC (NON‑WHEELED, NON‑POWERED) 880.6140

80 FRK CHAIR, EXAMINATION, AND TREATMENT 880.6140

80 FRL MEDICAL ABSORBENT FIBER 880.5300

80 FRP PEDIATRIC POSITION HOLDER 880.5680

80 FSD BINDER, ABDOMINAL 880.5160

80 FSL STRETCHER, HAND CARRIED 880.6900

80 IKY NON‑POWERED FLOTATION THERAPY MATTRESS 880.5150

80 KIA COVER, CAST 880.6185

80 KME MEDICAL DISPOSABLE BEDDING 880.6060

80 KMO BINDER, ELASTIC 880.5160

80 KYR BAG, ICE 880.6050

80 KYT BATTERY POWERED EXAM LIGHT 880.6350

80 KYW GRADUATED LIQUID MEDICATION 880.6430

80 KYX LIQUID MEDICATION DISPENSER 880.6430

80 LBJ VEIN STABILIZATION DEVICE 880.6980

**IMMUNOLOGY DEVICES**

82 ‑‑‑ (No devices have been exempted)

**MICROBIOLOGY DEVICES**

(Final Regulation Published in November 9, l982 [FEDERAL]{.underline}
[REGISTER;]{.underline}

EFFECTIVE DATE: 12/9/82)

83 GMB LIGHT, WOOD\'S FLUORESCENCE 866.2600

83 JTB MEDIA DISPENSING/STACKING DEVICES 866.2440

83 JTM ANAEROBIC GLOVE BOX 866.2120

83 JTQ INCUBATORS/WATER BATHS, ALL 866.2540

83 KZC MANUAL COLONY COUNTER 866.2180

**NEUROLOGY DEVICES**

(Final Regulation Published in September 4, 1979 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 10/4/79)

84 GWI TWO POINT DISCRIMINATOR 882.1200

84 GWX TUNING FORK 882.1525

84 GWZ PERCUSSOR 882.1700

84 GXB ESTHESIOMETER 882.1500

**OBSTETRICAL/GYNECOLOGICAL**

85 ‑‑‑ (No devices have been exempted)

**OPHTHALMIC DEVICES**

(Final Regulation Published in September 2, 1987 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 10/2/87)

86 HIT TESTER, COLOR VISION 886.1170

86 HJC OCULAR ESTHESIOMETER 886.1040

86 HJF MAGNIFIER, HAND-HELD, LOW-VISION 886.5540

86 HJH BINOCULAR LOUPE, LOW POWER 886.5120

86 HJI LENS, FUNDUS, HRUBY, DIAGNOSTIC 886.1395

86 HJJ LENS, FRESNEL, FLEXIBLE, DIAGNOSTIC 886.1390

86 HJL LENS, CONDENSING, DIAGNOSTIC 886.1380

86 HKB TELESCOPE, HAND-HELD, LOW-VISION 886.5870

86 HKC SPECTACLE MICROSCOPE, LOW-VISION 886.5540

86 HKD TAPE, NYSTAGMUS 886.1905

86 HKF MIRROR, HEADBAND, OPHTHALMIC 886.1500

86 HKG FORNISXCOPE 886.1320

86 HKK TELESCOPE, SPECTACLE, LOW-VISION 886.5870

86 HKM RETINOSCOPE, BATTERY‑POWERED 886.1780

86 HKN REFRACTOR, MANUAL, NON‑POWERED, 886.1770

86 HKQ PRISM, ROTARY, OPHTHALMIC 886.1665

86 HKR LENS, MADDOX 886.1400

86 HKT PRISM, FRESNEL, OPHTHALMIC 886.1655

86 HKW PRISM, BAR, OPHTHALMIC 886.1650

86 HLC INSTRUMENT, MEASURING, STEREOPSIS 886.1460

86 HLE RULER, NEAR POINT (PUNCTOMETER) 886.1790

86 HLH PUPILLOMETER, MANUAL 886.1700

86 HLJ OPHTHALMOSCOPE BATTERY‑POWERED 886.1570

86 HLK SCREEN, TANGENT, TARGET 886.1810

BATTERY-POWERED

86 HLN GAUGE, LENS, OPHTHALMIC 886.1420

86 HLO TEST, SPECTACLE DISSOCIATION, 886.1910

BATTERY-POWERED

86 HLP TARGET, FUSION AND STEREOSCOPIC 886.1880

86 HLR KERATOSCOPE, BATTERY‑POWERED 886.1350

86 HMD CHAIR, OPHTHALMIC, MANUAL 886.1140

86 HMG STAND, INSTRUMENT, OPHTHALMIC 886.1860

86 HMJ SCREEN, TANGENT, PROJECTION 886.1810

BATTERY-POWERED

86 HMM DISTOMETER 886.1190

86 HMQ MARKER, SCLERA 886.4570

86 HMR MARKER, OCULAR 886.4570

86 HMS DRUM, OPHTHALMIC KNIFE TEST 886.4230

86 HMX CANNULA, OPHTHALMIC 886.4350

86 HMZ TRABECULOTOME 886.4350

86 HNA SPUD, OPHTHALMIC 886.4350

86 HNB SPOON, OPHTHALMIC 886.4350

86 HNC SPECULA, OPHTHALMIC 886.4350

86 HND SPATULA, OPHTHALMIC 886.4350

86 HNE SNARE, ENUCLEATING 886.4350

86 HNF SCISSORS, OPHTHALMIC 886.4350

86 HNG RONGEUR, LACHRYMAL SAC 886.4350

86 HNH RING, OPHTHALMIC (FLIERINGA) 886.4350

86 HNI RETRACTOR, OPHTHALMIC 886.4350

86 HNJ PUNCH, CORNEO-SCLERAL 886.4350

86 HNK PROBE, TRABECULOTOMY 886.4350

86 HNL PROBE, LACHRYMAL 886.4350

86 HNM NEEDLE, OPHTHALMIC SUTURING 886.4350

86 HNN KNIFE, OPHTHALMIC 886.4350

86 HNP INTRODUCER, SPHERE 886.4350

86 HNQ HOOK, OPHTHALMIC 886.4350

86 HNR FORCEPS, OPHTHALMIC 886.4350

86 HNS EXPRESSOR 886.4350

86 HNT ERISOPHAKE 886.4350

86 HNW DILATOR, LACHRYMAL 886.4350

86 HNX DEPRESSOR, ORBITAL 886.4350

86 HNY CYSTOTOME 886.4350

86 HNZ CURETTE, OPHTHALMIC 886.4350

86 HOA COMPRESSOR, ORBITAL 886.4350

86 HOB CLAMP, MUSCLE, OPHTHALMIC 886.4350

86 HOC CLIP, IRIS RETRACTOR 886.4350

86 HOD CLAMP, EYELID, OPHTHALMIC 886.4350

86 HOE CALIPER, OPHTHALMIC 886.4350

86 HOF BURR, CORNEAL, MANUAL 886.4350

86 HOH SPECTACLE, OPERATING (LOUPE), 886.4770

OPHTHALMIC

86 HOI SPECTACLE, MAGNIFYING 886.5840

86 HOJ SCREEN, TANGENT, TARGET 886.1810

86 HOL SCREEN, TANGENT, FELT (CAMPIMETER) 886.1810

86 HON PERIMETER, MANUAL 886.1605

86 HOP CAMPIMETER, STEREO, BATTERY-POWERED 886.1810

86 HOQ GRID, AMSLER 886.1330

86 HOR SIMULITAN (INCLUDING CROSSED CYLINDER) 886.1840

86 HOT AID, VISION, IMAGE-INTENSIFICATION, 886.5910

BATTERY-POWERED

86 HOW DRUM, OPTOKINETIC 886.1200

86 HOX CHART, VISUAL ACUITY 886.1150

86 HOY SHIELD, EYE, OPHTHALMIC 886.4750

86 HPA FRAME, TRIAL, OPHTHALMIC 886.1415

86 HPB CLIP, LENS, TRIAL, OPHTHALMIC 886.1410

86 HPD LENS, BAGOLINI 886.1375

86 HPE AID, VISION, OPTICAL, BATTERY-POWERED 886.5915

86 HPN MAGNET, PERMANENT 886.4445

86 HRH TREPHINE, MANUAL, OPHTHALMIC 886.4350

86 HRK TABLE, INSTRUMENT, MANUAL, OPHTHALMIC 886.4855

**ORTHOPEDIC DEVICES**

(Final Regulation Published in September 4, 1987 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 10/5/87)

87 HST APPARATUS, TRACTION, NON‑POWERED 888.5850

ORTHOPEDIC

87 JQZ TRACTION COMPONENT, NON-INVASIVE 862.2050

87 LGF CAST COMPONENT 888.5940

87 LGG MANUAL CAST APPLICATION AND REMOVAL 888.5980 INSTRUMENT

**HEMATOLOGY AND PATHOLOGY DEVICES**

(Final Regulation Published in September 12, 1980 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 10/14/80)

88 GFR NEW METHYLENE BLUE STAIN 864.1850

88 GGD CRYSTAL VIOLET FOR HEMATOLOGY 864.1850

88 GGH IRON STAINS 864.1850

88 GGI PERIODIC ACID SCHIFF STAIN 864.1850

88 GHP BRILLIANT CRESYL BLUE 864.1850

88 GIX TOLUIDINE BLUE 864.1850

88 GJH RETICULOCYTE STAIN 864.1850

88 GJJ HEINZ BODY STAINS 864.1850

88 GJL ROMANOWSKY STAINS 864.1850

88 GJO SLIDES AND COVERSLIPS 864.3010

88 GJY MICROSCOPE 864.3600

88 GLP GIEMSA STAIN 864.1850

88 HYB EOSIN Y 864.1850

88 HYC FAST GREEN 864.1850

88 HYD FAST RED SALT B 864.1850

88 HYE FONTANNA SILVER SOLUTION 864.1850

88 HYH GOLD CHLORIDE 864.1850

88 HYI GRAMS IODINE 864.1850

88 HYJ HEMATOXYLIN 864.1850

88 HYK HEMATOXYLIN HARRIS\'S 864.1850

88 HYL HEMATOXYLIN MAYER\'S 864.1850

88 HYO HEMATOXYLIN WEIGERT\'S 864.1850

88 HYQ IRON CHLORIDE‑WEIGERT 864.1850

88 HYR LEUCO‑PATENT BLUE 864.1850

88 HYS LIGHT GREEN 864.1850

88 HYW MALLORY\'S TRICHROME STAIN 864.1850

88 HYY METANIL YELLOW 864.1850

88 HYZ METHENAMINE SILVER 864.1850

88 HZA METHYL GREEN 864.1850

88 HZC MUCICARMINE 864.1850

88 HZD MULLER\'S COLLOIDAL IRON 864.1850

88 HZE NILE BLUE 864.1850

88 HZF NUCLEAR FAST RED 864.1850

88 HZG OIL RED O 864.1850

88 HZH ORANGE G 864.1850

88 HZJ PAPANICOLAOU STAIN 864.1850

88 HZL PHLOXINE B 864.1850

88 HZM PHOSPHOTUNGSTIC ACID HEMATOXYLIN 864.1850

88 HZN PICRO METHYL BLUE 864.1850

88 HZO PONCEAU STAIN 864.1850

88 HZP PYRONIN 864.1850

88 HZQ RED VIOLET ‑ LB 864.1850

88 HZR RESORCIN FUCHSIN 864.1850

88 HZS SAFRANIN 864.1850

88 HZT SCHIFF REAGENT 864.1850

88 HZX SILVER NITRATE 864.1850

88 HZY SIRIUS RED 864.1850

88 HZZ SUDAN BLACK B 864.1850

88 IAA TITAN YELLOW 864.1850

88 IAB TOLUIDINE BLUE 864.1850

88 IAC VAN GIESON\'S STAIN 864.1850

88 IAD VAN GIESON\'S PICRO‑FUCHSIN 864.1850

88 IAE WEIGERT\'S IRON HEMATOXYLIN 864.1850

88 IAF WRIGHT\'S STAIN 864.1850

88 IAM LUGOL\'S SOLUTION 864.4010

88 IAT APATHY\'S GUM SYRUP 864.4010

88 IAW COLLODION 864.4010

88 IBJ ICROSCOPE, LIGHT 864.3600

88 IBK MICROSCOPE, FLUORESCENCE/UV 864.3600

88 IBL MICROSCOPE, INVERTED STAGE, TISSUE 864.3600

> CULTURE

88 IBM MICROSCOPE, PHASE CONTRAST 864.3600

88 ICC EOSIN B 864.1850

88 ICD DARROW RED 864.1850

88 ICF CRYSTAL VIOLET FOR HISTOLOGY 864.1850

88 ICG CRESYL VIOLET ACETATE 864.1850

88 ICH CONGO RED 864.1850

88 ICI CHROME ALUM HEMATOXYLIN 864.1850

88 ICL CARBOL FUCHSIN 864.1850

88 ICM BRILLIANT YELLOW 864.1850

88 ICN BIEBRICH SCARLET 864.1850

88 ICO BEST\'S CARMINE 864.1850

88 ICQ AZURE A 864.1850

88 ICR AZOCARMINE B 864.1850

88 ICS AZOCARMINE G 864.1850

88 ICT AZAN COUNTERSTAIN 864.1850

88 ICX ANILINE 864.1850

88 ICY ANILINE ACID FUCHSIN 864.1850

88 ICZ AMMONIACAL SILVER HYDROXIDE 864.1850

SILVER NITRATE

88 IDA ALCIAN BLUE 864.1850

88 IDB ALDEHYDE FUCHSIN 864.1850

88 IDC ACRIDINE ORANGE 864.1850

88 IDD ALIZARIN RED 864.1850

88 IDE ACID HEMATEIN 864.1850

88 IDF ACID FUCHSIN 864.1850

88 IDL MICROTOME, ACCESSORIES 864.3010

88 IDM MICROTOME, ULTRA 864.3010

88 IDN MICROTOME, FREEZING ATTACHMENT 864.3010

88 IDO MICROTOME, ROTARY 864.3010

88 IDP MICROTOME, CRYOSTAT 864.3010

88 IDQ INFILTRATOR 864.3010

88 IDR OVENS, PARAFFIN 864.3010

88 IDS MELTING POT, PARAFFIN 864.3010

88 IDT MELTING POINT APPARATUS, PARAFFIN 864.3010

88 IDW DISPENSERS, PARAFFIN 864.3010

88 IDX SIEVES, TISSUE 864.3010

88 IDY FLOTATION BATHS, TISSUE 864.3010

88 IDZ CASSETTES, TISSUE 864.3010

88 IEG TABLE, SLIDE WARMING 864.3010

88 IEH LAMPS, SLIDE WARMING 864.3010

88 IER OLYETHYLENE GLYCOL (CARBOWAX) 864.4010

88 IEX GELATIN 864.4010

88 IEZ CELLOIDIN 864.4010

88 IFF DECALCIFIER SOLUTION, ELECTROLYTIC 864.4010

88 IFH ZENKER\'S SOLUTION 864.4010

88 IFI SPRAYS, SYNTHETIC, SMEAR 864.4010

88 IFJ RICHARDSON GLYCOL FIXATIVE 864.4010

88 IFL POLETHYLENE GLYCOL PRESERVATIVE 864.4010

88 IFN ORTH\'S SOLUTION 864.4010

88 IFO NEWCOMER\'S SOLUTION 864.4010

88 IFP FORMALIN, NEUTRAL BUFFERED 864.4010

88 IFQ MERCURIC CHLORIDE FORMULATIONS 864.4010

88 IFS HELLY SOLUTION 864.4010

88 IFZ GELATIN FOR SPECIMEN ADHESION 864.4010

88 IGB FORMALIN‑SODIUM ACETATE SOLUTION 864.4010

88 IGC FORMALIN‑SALINE 864.4010

88 IGD FORMOL CALCIUM SOLUTION 864.4010

88 IGE FORMALIN AMMONIUM BROMIDE 864.4010

88 IGF FORMALIN‑ALCOHOL‑ACETIC ACID 864.4010

88 IGG FORMALDHYDE (FORMALIN, FORMOL) 864.4010

88 IGK CLARKE\'S SOLUTION 864.4010

88 IGM CARNOY\'S SOLUTION 864.4010

88 IGN BOUIN\'S FLUID 864.4010

88 IHJ BLENDORS FOR SPUTUM 864.3010

88 IJZ CLEARING OIL 864.4010

88 JCC PH BUFFERS 864.4010

88 JCE ISOTONIC SOLUTION 864.4010

88 JCH ESTERASE 864.1850

88 JCI ACID PHOSPHATASE, CYTOCHEMICAL 864.1850

88 JTS STAINS, MICROBIOLOGIC, ALL 864.1850

88 KDX DECALCIFIER SOLUTION, ACID CONTAINING 864.4010

88 KDY CHELATING AGENTS FOR DECALIFICATION 864.4010

88 KDZ DEALCIFIER DEVICES, ELECTROLYTIC 864.3010

88 KEE OSMIUM TETROXIDE 864.4010

88 KEF PARAFORMALDEHYDE 864.4010

88 KEG LAMPS, MICROSCOPE 864.4010

88 KEH MICROMETERS, MICROSCOPE 864.3600

88 KEI CONDENSERS, MICROSCOPE 864.3600

88 KEJ STAGES, MICROSCOPE 864.3600

88 KEL ALBUMIN‑BASED ADHESIVES 864.4010

88 KEM CLEARING AGENTS 864.4010

88 KEO PARAFFIN, ALL FORMULATIONS 864.4010

88 KEP OIL SOLUBLE MOUNTING MEDIA 864.4010

88 KEQ WATER SOLUBLE MOUNTING MEDIA 864.4010

88 KER EMBEDDING CONTAINER 864.3010

88 KES COVERSLIPS, MICROSCOPE SLIDE 864.3010

88 KET FILTER, CELL COLLECTION, TISSUE 864.3010

88 KEW SLIDES, MICROSCOPE 864.3010

88 KFC METHYLENE BLUE, TISSUE STAIN 864.1850

88 KFD ANILINE BLUE 864.1850

88 KFE NEUTRAL RED 864.1850

88 KFL MICROTOME, SLIDING 864.3010

88 KIY CHAMBER, SLIDE CULTURE 864.2240

88 KIZ DISH, TISSUE CULTURE 864.2240

88 KJA FLASK, TISSUE CULTURE 864.2240

88 KJB ROLLER APPARATUS 864.2240

88 KJC ROLLER BOTTLE, TISSUE CULTURE 864.2240

88 KJD SPINNER FLASK 864.2240

88 KJE SPINNER SYSTEM, CELL CULTURE 864.2240

88 KJF SUSPENSION SYSTEM, CELL CULTURE 864.2240

88 KJG TUBE, TISSUE CULTURE 864.3010

88 KJH PERFUSION APPARATUS 864.2240

88 KJK AURAMINE O 864.1850

88 KJL AZURE C 864.1850

88 KJM BISMARCK BROWN Y 864.1850

88 KJN BRILLIANT CRESYL BLUE 864.1850

88 KJO BRILLIANT GREEN 864.1850

88 KJP CARMINE 864.1850

88 KJQ CHLORAZOL BLACK E 864.1850

88 KJR ERYTHROSIN B 864.1850

88 KJS ETHYL EOSIN 864.1850

88 KJT INDIGOCARMINE 864.1850

88 KJW JANUS GREEN B 864.1850

88 KJX JENNER STAIN 864.1850

88 KJY MALACHITE GREEN 864.1850

88 KJZ MARTIUS YELLOW 864.1850

88 KKA METHYL ORANGE 864.1850

88 KKB METHYL VIOLET 2B 864.1850

88 KKC METHYLENE VIOLET 864.1850

88 KKD NIGROSIN 864.1850

88 KKE ORANGE II 864.1850

88 KKF ORCEIN 864.1850

88 KKG PROTARGOL S 864.1850

88 KKH RESAUZRIN TABLET 864.1850

88 KKI ROSE BENGAL 864.1850

88 KKJ SUDAN III 864.1850

88 KKK SUDAN IV 864.1850

88 KKL THIONIN 864.1850

88 KKM METHYLENE BLUE THIOCYANATE 864.1850

88 KKP SILVER CARBONATE SOLUTION 864.1850

88 KKQ SODIUM PERIODATE 864.1850

88 KKR POTASSIUM PERIODATE 864.1850

88 KKS PERIODIC ACID 864.1850

88 KKT HEMATOXYLIN EHRLICH\'S 864.1850

88 KKW BASIC FUCHSIN 864.1850

88 KQD HEMATOLOGY STAINS 864.4010

**PHYSICAL MEDICINE DEVICES**

(Final Regulation Published in November 23, 1983 [Federal]{.underline}
[Register]{.underline};

EFFECTIVE DATE: 12/23/83)

89 IKW UTENSIL, HOMEMAKING 890.5050

89 IKX AID, TRANSFER 890.5050

89 ILC UTENSIL, EATING 890.5050

89 ILD ADAPTOR, DRESSING 890.5050

89 ILE SLING, ARM, OVERHEAD SUPPORTED 890.3475

89 ILG STOCKING, ELASTIC 890.3475

89 ILH SPLINT, HAND, AND COMPONENTS 890.3475

89 ILI SLING, ARM 890.3640

89 ILP SYSTEM, COMMUNICATION, NON‑POWERED 890.3700

89 ILS ADAPTOR, HYGIENE 890.5050

89 ILT ADAPTOR, RECREATIONAL 890.5050

89 ILW ADAPTOR, GROOMING 890.5050

89 ILZ ACCESSORIES, TRACTION 890.5925

89 IMA HEAT PACK, MOIST 890.5730

89 IME PACK, HOT OR COLD, REUSABLE 890.5700

89 IMS SUPPORT, HEAD AND TRUNK, WHEELCHAIR 890.3910

89 IMX BOARD, LAP, WHEELCHAIR 890.3910

89 IMY ARMBOARD, WHEELCHAIR 890.3910

89 IMZ HOLDER, CRUTCH AND CANE, WHEELCHAIR 890.3910

89 INC CUFF, PUSHER, WHEELCHAIR 890.3910

89 INE SLING, OVERHEAD SUSPENSION, WHEELCHAIR 890.3910

89 INF SCALE, PLATFORM, WHEELCHAIR 890.3940

89 INP TIPS AND PADS, CANE, CRUTCH AND WALKER 890.3790

89 INT PLINTH 890.3520

89 IOD COMPONENTS, EXERCISE 890.5350

89 IOE BARS, PARALLEL, EXERCISE 890.5370

89 IOG TREADMILL, MECHANICAL 890.5370

89 ION EXERCISER, NON‑MEASURING 890.5370

89 IOY SUPPORT, ARM 890.3475

89 IOZ SPLINT, ABDUCTION, CONGENITAL HIP 890.3665

DISLOCATION

89 IPG SHOE, CAST 890.3025

89 IPM COVER, LIMB 890.3025

89 IPR CRUTCH 890.3150

89 IPS CANE 890.3075

89 IPT ORTHOSIS, THORACIC 890.3490

89 IPW ORTHOSIS, SACROILIAC, SOFT 890.3490

89 IPX ORTHOSIS, RIB FRACTURE, SOFT 890.3490

89 IPY ORTHOSIS, LUMBO‑SACRAL 890.3490

89 IQE ORTHOSIS, LUMBAR 890.3490

89 IQF ORTHOSIS, CERVICAL‑THORACIC, RIGID 890.3490

89 IQG ADAPTOR, HOLDER, SYRINGE 890.5050

89 IQI ORTHOSIS, LIMB BRACE 890.3475

89 IQJ SPLINT, CLAVICLE 890.3490

89 IQK ORTHOSIS, CERVICLE 890.3490

89 IQM SPLINT, TEMPORARY, TRAINING 890.3025

89 IQO DEVICE, PROSTHESIS ALIGNMENT 890.3025

89 IQP ROTATOR, TRANSVERSE 890.3025

89 IQQ JOINT, SHOULDER, EXTERNAL LIMB COMPONENT 890.3420

89 IQW HOOK, EXTERNAL LIMB COMPONENT, POWERED 890.3420

89 IQX HOOK, EXTERNAL LIMB COMPONENT, MECHANICAL 890.3420

89 IQZ HAND, EXTERNAL LIMB COMPONENT, POWERED 890.3420

89 IRA HAND, EXTERNAL LIMB COMPONENT, MECHANICAL 890.3420

89 IRD JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 890.3420

MECHANICAL

89 IRE JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 890.3420

POWERED

89 ISH ANKLE/FOOT, EXTERNAL LIMB COMPONENT 890.3420

89 ISL JOINT, HIP, EXTERNAL LIMB COMPONENT 890.3420

89 ISM PYLON, POST SURGICAL 890.3025

89 ISN CABLE 890.3420

89 ISP VALVE, PROSTHESIS 890.3420

89 ISR BAND OR BELT, PELVIC SUPPORT 890.3425

89 ISS PROSTHESIS, THIGH SOCKET, EXTERNAL 890.3420

COMPONENT

89 ISY JOINT, KNEE, EXTERNAL LIMB COMPONENT 890.3420

89 ISZ UNIT, WRIST, EXTERNAL LIMB COMPONENT, 890.3420

MECHANICAL

89 ITC STIRRUP, EXTERNAL BRACE COMPONENT 890.3410

89 ITG BANDAGE, CAST 890.3025

89 ITJ WALKER, MECHANICAL 890.3825

89 ITM CAGE, KNEE 890.3475

89 ITN SPLINT, DENIS BROWN 890.3675

89 ITO TWISTER, BRACE SETTING 890.3410

89 ITQ JOINT, KNEE, EXTERNAL BRACE 890.3475

89 ITS JOINT, HIP, EXTERNAL BRACE 890.3475

89 ITW JOINT, ANKLE, EXTERNAL BRACE 890.3475

89 KGH UNIT, WRIST, EXTERNAL LIMB COMPONENT, 890.3420

POWERED

89 KHY CANE, SAFETY WALK 890.3075

89 KND ACCESSORIES, WHEELCHAIR 884.5390

89 KNL BOARD, SCOOTER, PRONE 890.5370

89 KNP ORTHOSIS, CORRECTIVE SHOE 890.3475

89 KTZ BATH, SITZ, NON‑POWERED 888.4150

**RADIOLOGICAL DEVICES**

(Final Regulation Published in January 20, 1988 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 2/19/88)

90 IWY HOLDER, HEAD, RADIOGRAPHIC 892.1920

90 IXF TEST PATTERN, RADIOGRAPHIC 892.1940

90 IXG PHANTOM, ANTHROPOMORPHIC, RADIOGRAPHIC 892.1950

**CLINICAL TOXICOLOGY DEVICES**

(Final Regulation Published in May 1, 1987 [FEDERAL
REGISTER]{.underline};

EFFECTIVE DATE: 7/30/87)

91 DJS UV LIGHT, TLC 862.2270

91 DKK DEVELOPING TANKS, TLC 862.2270

91 DLC ATOMIZER, TLC 862.2270

91 DPA THIN LAYER CHROMATOGRAPHY, APPARATUS, 862.2270

GENERAL USE