The following data is part of a premarket notification filed by Medical Reports Exchange, Inc. with the FDA for Plastic Sunglasses.
| Device ID | K964316 |
| 510k Number | K964316 |
| Device Name: | PLASTIC SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MEDICAL REPORTS EXCHANGE, INC. 2112 CROSS TRAILS RD. Baltimore, MD 21244 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith MEDICAL REPORTS EXCHANGE, INC. 2112 CROSS TRAILS RD. Baltimore, MD 21244 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1996-12-17 |