The following data is part of a premarket notification filed by Micron Eyewear Manufactory Co., Ltd. with the FDA for Sunglasses (non-prescription).
Device ID | K964943 |
510k Number | K964943 |
Device Name: | SUNGLASSES (NON-PRESCRIPTION) |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | MICRON EYEWEAR MANUFACTORY CO., LTD. UNIT 20, 5/F, WELL FUNG IND. CTR., 68 TA CHUEN PING ST., Kwai Chung, N.t., HK |
Contact | Chris Wong Siu Hing |
Correspondent | Chris Wong Siu Hing MICRON EYEWEAR MANUFACTORY CO., LTD. UNIT 20, 5/F, WELL FUNG IND. CTR., 68 TA CHUEN PING ST., Kwai Chung, N.t., HK |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-10 |
Decision Date | 1997-02-25 |