The following data is part of a premarket notification filed by Simon Marketing, Inc. with the FDA for Sunglasses.
Device ID | K934837 |
510k Number | K934837 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SIMON MARKETING, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
Contact | Donald R Stone |
Correspondent | Donald R Stone SIMON MARKETING, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-05 |
Decision Date | 1993-12-08 |