The following data is part of a premarket notification filed by K Mart Apparel Corp. with the FDA for Sunglasses.
Device ID | K900944 |
510k Number | K900944 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | K MART APPAREL CORP. 7373 WEST SIDE AVE. North Bergen, NJ 07047 |
Contact | Steven M Kott |
Correspondent | Steven M Kott K MART APPAREL CORP. 7373 WEST SIDE AVE. North Bergen, NJ 07047 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-28 |
Decision Date | 1990-07-05 |