The following data is part of a premarket notification filed by Wing Shing Optical Manufacturers Ltd. with the FDA for Sunglasses.
Device ID | K922464 |
510k Number | K922464 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | WING SHING OPTICAL MANUFACTURERS LTD. 4/F., ROOM 1, SINO INDUSTRIAL PLAZA, 9 KAI CHEUNG ROAD Kowloon Bay, Kowloon, HK |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-26 |
Decision Date | 1993-01-27 |