Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf8-k083042
Timestamp: 2019-06-18 09:19:21
Document Index: 634108308

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807', 'art 21']

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DEC 1 8 2008
510(k) Section 5 Wound Flush, Sterile Water &amp; Sterile Normal Saline
5 - 510(k) Summary with 21 CFR 807.87(h) and 21 CFR 807.92) (In accordance 1. Submatter's name and address: Nurse Assist Incorporated 3400 Northern Cross Boulevard Fort Worth, Texas 76137 2. Submitter's telephone number and fax number: Tel: (817) 231-1300 Fax: (817) 231-1500 3. Contact person: Bill Kanewske - Vice President of Operations 4. Date this 510(k) summary prepared: 2008 October 7, 5. Trade/proprietary name of the device: Wound Flush, Sterile Water &amp; Sterile Normal Saline 6. Device classification Unclassified, pre-amendment device Product code FRO 7. Legally marketed predicate devices to which substantial equivalence is claimed: * Welcon Sterile Water and Sterile 0.9% Normal Saline - K973784 and K003402 * Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corporation - K070463 * BioDerm Wound Spray; BioDenrn Sciences, Incorporated - K042084 * Blairex Wound Wash Saline, Blairex Laboratories, Incorporated - unknown 8. Description of the device that is the subject of this premarket notification: The Wound Flush, Sterile Water &amp; Sterile Normal Saline device is a wound and device *cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP &lt;31I&gt;. The subject device is offered in various bottle and cup sizes with and without a spray applicator
9. Intended use and indication for use:
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. * For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree bums, cuts, abrasions and minor skin irritations and for device irrigation.
10. Technological characteristics:
The mechanical action of fluid moving across the wound or device provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. This concludes the 510(k) Summary.
Nurse Assist, Inc. % Shotwell and Carr, Inc. Ms. Denice Gallagher Regulatory Consultant 1415 Halsey Way, Suite 304 Carrollton, Texas 75007-4455
DEC 18 70!!
Re: K083042 Trade/Device Name: Wound Flash, Sterile Water &amp; Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: October 7, 2008 Received: October 14, 2008 Dear Ms. Gallagher: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Ms. Denice Gallagher
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours,
5 10(k) Section 4 Wound Flush, Sterile Water &amp; Sterile Normal Saline
4 - Indications for Use
5 10(k) Number (if known):
Unknown - not yet assigned by FDA
Device Name: Wound Flush, Sterile Water &amp; Normal Saline Indications for Use: For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
X Use Prescription (Part 21 CFR 801 SubpartD)
Use C)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number ,
Page 1 of 1 (PostedNovember 13, 2003)
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