The following data is part of a premarket notification filed by Tung Fang Mei Shieh Co., Ltd. with the FDA for Sunglasses.
Device ID | K936033 |
510k Number | K936033 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | TUNG FANG MEI SHIEH CO., LTD. SUNNY SUNGLASSES 260 S. LOS ANGELES STREET Los Angeles, CA 90012 |
Contact | Anthony Su |
Correspondent | Anthony Su TUNG FANG MEI SHIEH CO., LTD. SUNNY SUNGLASSES 260 S. LOS ANGELES STREET Los Angeles, CA 90012 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-17 |
Decision Date | 1994-02-22 |