The following data is part of a premarket notification filed by Kai Tai Optical Mfg. Co. Ltd. with the FDA for Sunglasses.
Device ID | K930659 |
510k Number | K930659 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | KAI TAI OPTICAL MFG. CO. LTD. 345 DES VOUEX ROAD, WEST CHEUNG KA INDU. BLDG. 16TH FL. Flat B, Hong Kong, HK |
Contact | Thomas Lau |
Correspondent | Thomas Lau KAI TAI OPTICAL MFG. CO. LTD. 345 DES VOUEX ROAD, WEST CHEUNG KA INDU. BLDG. 16TH FL. Flat B, Hong Kong, HK |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-09 |
Decision Date | 1994-02-16 |