The following data is part of a premarket notification filed by Sun Coast Merchandise Corp. with the FDA for Sunglasses.
| Device ID | K941638 |
| 510k Number | K941638 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN COAST MERCHANDISE CORP. 6405 RANDOLPH ST. Commerce, CA 90040 |
| Contact | Vidya Bhavnani |
| Correspondent | Vidya Bhavnani SUN COAST MERCHANDISE CORP. 6405 RANDOLPH ST. Commerce, CA 90040 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-04 |
| Decision Date | 1994-05-17 |