The following data is part of a premarket notification filed by Mountain Shades, Inc. with the FDA for Mountain Shades -nonprescription Sunglasses.
| Device ID | K940741 |
| 510k Number | K940741 |
| Device Name: | MOUNTAIN SHADES -NONPRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MOUNTAIN SHADES, INC. P.O. BOX 609 Vail, CO 81658 |
| Contact | Ken Fox |
| Correspondent | Ken Fox MOUNTAIN SHADES, INC. P.O. BOX 609 Vail, CO 81658 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-17 |
| Decision Date | 1994-06-03 |