The following data is part of a premarket notification filed by Walmart Stores with the FDA for Sunglasses.
Device ID | K954639 |
510k Number | K954639 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | WALMART STORES 702 S.W. 8TH ST. - DEPT. 8023 Bentonville, AR 72716 -8023 |
Contact | Susan Duffy |
Correspondent | Susan Duffy WALMART STORES 702 S.W. 8TH ST. - DEPT. 8023 Bentonville, AR 72716 -8023 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-10 |
Decision Date | 1995-10-25 |