The following data is part of a premarket notification filed by Glascal Industries, Ltd. with the FDA for Sunglasses.
| Device ID | K932844 |
| 510k Number | K932844 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | GLASCAL INDUSTRIES, LTD. TAI PING INDU. CENTRE, BLK 4 51A, TING KOK RD. Tai Po,nt, Hong Kong, HK |
| Contact | 8th Fl. |
| Correspondent | 8th Fl. GLASCAL INDUSTRIES, LTD. TAI PING INDU. CENTRE, BLK 4 51A, TING KOK RD. Tai Po,nt, 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 | 1993-06-10 |
| Decision Date | 1994-04-12 |