The following data is part of a premarket notification filed by Mountain Shades, Inc. with the FDA for Ski Vector Non-prescription Sunglasses.
Device ID | K940831 |
510k Number | K940831 |
Device Name: | SKI VECTOR NON-PRESCRIPTION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | MOUNTAIN SHADES, INC. 910 NOTTINGHAM RD. #N1 P.O. BOX 5130 Avon, CO 81620 |
Contact | Ken Fox |
Correspondent | Ken Fox MOUNTAIN SHADES, INC. 910 NOTTINGHAM RD. #N1 P.O. BOX 5130 Avon, CO 81620 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-22 |
Decision Date | 1994-06-03 |