The following data is part of a premarket notification filed by Blink Designs, Inc. with the FDA for Faconnable Eyewear (sunglasses).
Device ID | K943568 |
510k Number | K943568 |
Device Name: | FACONNABLE EYEWEAR (SUNGLASSES) |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | BLINK DESIGNS, INC. 6307 DESOTO AVE., SUITE A Woodland Hills, CA 91367 |
Contact | Brian Jablon |
Correspondent | Brian Jablon BLINK DESIGNS, INC. 6307 DESOTO AVE., SUITE A Woodland Hills, CA 91367 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-22 |
Decision Date | 1994-08-11 |