The following data is part of a premarket notification filed by Sun And Young Sunglasses Co., Ltd. with the FDA for Sunglasses.
Device ID | K932940 |
510k Number | K932940 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SUN AND YOUNG SUNGLASSES CO., LTD. 2 FL. NO. 113, TZU-CHIANG RD., YUNGKANG HSIANG,TAINAN HSIEN Taiwan,the Republic Of Ch, TW |
Contact | Michael Hsu |
Correspondent | Michael Hsu SUN AND YOUNG SUNGLASSES CO., LTD. 2 FL. NO. 113, TZU-CHIANG RD., YUNGKANG HSIANG,TAINAN HSIEN Taiwan,the Republic Of Ch, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-16 |
Decision Date | 1993-09-20 |