The following data is part of a premarket notification filed by Sunnex Fashion Corp. with the FDA for Ott Sunglasses.
| Device ID | K932135 |
| 510k Number | K932135 |
| Device Name: | OTT 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 | Johnson |
| Correspondent | Johnson 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 | 1993-05-03 |
| Decision Date | 1993-08-06 |