The following data is part of a premarket notification filed by Hip Shing Fat Co., Ltd. with the FDA for Sunglasses.
Device ID | K974441 |
510k Number | K974441 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | HIP SHING FAT CO., LTD. 1829-1832 STAR HOUSE, TST Kowloon, HK |
Contact | Peter K C. Lee |
Correspondent | Peter K C. Lee HIP SHING FAT CO., LTD. 1829-1832 STAR HOUSE, TST Kowloon, HK |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-25 |
Decision Date | 1998-01-09 |