The following data is part of a premarket notification filed by Asics Tiger Corp. with the FDA for Asics Sunglasses.
Device ID | K933905 |
510k Number | K933905 |
Device Name: | ASICS SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | ASICS TIGER CORP. 10540 TALBERT AVE. Fountain Valley, CA 92708 |
Contact | Nancy Burns |
Correspondent | Nancy Burns ASICS TIGER CORP. 10540 TALBERT AVE. Fountain Valley, CA 92708 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-11 |
Decision Date | 1993-10-18 |