The following data is part of a premarket notification filed by Sunnex Fashion Corp. with the FDA for Sunnex Fashion Corp. Non-prescription Sunglasses.
Device ID | K951504 |
510k Number | K951504 |
Device Name: | SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SUNNEX FASHION CORP. 134 TA YUNG RD. YUNG KANG HSIANG,TAINAN HSIEN Tawain, R.o.c., CN |
Contact | Jeou Sheng, Lin |
Correspondent | Jeou Sheng, Lin SUNNEX FASHION CORP. 134 TA YUNG RD. YUNG KANG HSIANG,TAINAN HSIEN Tawain, R.o.c., CN |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-03 |
Decision Date | 1995-04-28 |