The following data is part of a premarket notification filed by Eyedesigns Corp. with the FDA for Spectacle Frames, Sunglasses.
Device ID | K936125 |
510k Number | K936125 |
Device Name: | SPECTACLE FRAMES, SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EYEDESIGNS CORP. #220 1-KA, NOWON-DONG, BUK-GU Daegu, Korea, KR 702081 |
Contact | D H Yoon |
Correspondent | D H Yoon EYEDESIGNS CORP. #220 1-KA, NOWON-DONG, BUK-GU Daegu, Korea, KR 702081 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-23 |
Decision Date | 1994-08-04 |