The following data is part of a premarket notification filed by Pyramid Handbags, Inc. with the FDA for Sunglasses.
| Device ID | K973526 |
| 510k Number | K973526 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | PYRAMID HANDBAGS, INC. 100 W. 33RD ST., SUITE 800 New York, NY 10001 |
| Contact | Jennifer Epstein |
| Correspondent | Jennifer Epstein PYRAMID HANDBAGS, INC. 100 W. 33RD ST., SUITE 800 New York, NY 10001 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-10-16 |