The following data is part of a premarket notification filed by Cheng Chen Hsing Enterp. & Fact. Co. Ltd. with the FDA for Cheng Chen Hsing Non-prescription Sunglasses.
| Device ID | K953808 |
| 510k Number | K953808 |
| Device Name: | CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | CHENG CHEN HSING ENTERP. & FACT. CO. LTD. NO. 7, TAI-YI-ONE ST. JENTE HSIANG Tainan Hsien, TW |
| Contact | Chen-chung Chiu |
| Correspondent | Chen-chung Chiu CHENG CHEN HSING ENTERP. & FACT. CO. LTD. NO. 7, TAI-YI-ONE ST. JENTE HSIANG Tainan Hsien, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-10-25 |