The following data is part of a premarket notification filed by Coil with the FDA for Pathfinder Sunglasses.
| Device ID | K971495 |
| 510k Number | K971495 |
| Device Name: | PATHFINDER SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | COIL 1314 NORTH HUNTER ST. SUITE 202 Baltimore, MD 21202 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith COIL 1314 NORTH HUNTER ST. SUITE 202 Baltimore, MD 21202 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-05-29 |