The following data is part of a premarket notification filed by Indoptica, S.a. with the FDA for Sunglasses.
| Device ID | K972850 |
| 510k Number | K972850 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | INDOPTICA, S.A. 1275 BEECHNUT PLACE, SUITE A Pomona, CA 91766 |
| Contact | John R Honey |
| Correspondent | John R Honey INDOPTICA, S.A. 1275 BEECHNUT PLACE, SUITE A Pomona, CA 91766 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-01 |
| Decision Date | 1997-09-17 |