The following data is part of a premarket notification filed by Chanel, Inc. with the FDA for Sunglasses.
Device ID | K946256 |
510k Number | K946256 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | CHANEL, INC. 5 EAST 57TH ST. New York, NY 10022 |
Contact | Beth Cohen |
Correspondent | Beth Cohen CHANEL, INC. 5 EAST 57TH ST. New York, NY 10022 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-23 |
Decision Date | 1995-01-17 |