The following data is part of a premarket notification filed by M. & S. Shillman, Inc. with the FDA for Children's Sunglasses.
Device ID | K901468 |
510k Number | K901468 |
Device Name: | CHILDREN'S SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | M. & S. SHILLMAN, INC. 1209 DEKALB AVE. BROOKLYN, NY 11221 |
Contact | CHARLES BERNARD |
Correspondent | CHARLES BERNARD M. & S. SHILLMAN, INC. 1209 DEKALB AVE. BROOKLYN, NY 11221 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-29 |
Decision Date | 1990-05-03 |