The following data is part of a premarket notification filed by Chungsin Kau Optical Mfy. Co. Ltd. with the FDA for Sunglasses.
Device ID | K962436 |
510k Number | K962436 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | CHUNGSIN KAU OPTICAL MFY. CO. LTD. BLOCK C, NO. 7,8/F, WAH TAT IND BLDG., 8-10, WAS SING ST. Kwai Chung, HK |
Contact | Hou Kau Chan |
Correspondent | Hou Kau Chan CHUNGSIN KAU OPTICAL MFY. CO. LTD. BLOCK C, NO. 7,8/F, WAH TAT IND BLDG., 8-10, WAS SING ST. Kwai Chung, HK |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-24 |
Decision Date | 1996-07-02 |