Source: https://www.federalregister.gov/documents/2003/08/18/03-55524/ophthalmic-devices
Timestamp: 2018-03-17 18:49:51
Document Index: 721474080

Matched Legal Cases: ['arts 800', '§\u2009886', '§\u2009886', 'art 807', '§\u2009886', 'art 820', '§\u2009820', '§\u2009820']

Federal Register :: Ophthalmic Devices
https://www.federalregister.gov/d/03-55524 https://www.federalregister.gov/d/03-55524
In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2003, in § 886.1500, on page 456, paragraph (b) is added to read as follows:
§ 886.1500
Headband mirror.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[FR Doc. 03-55524 Filed 8-15-03; 8:45 am]