The following data is part of a premarket notification filed by Chia Hui Spectacles Mfg. Corp. with the FDA for Non-prescription Sunglasses.
Device ID | K974852 |
510k Number | K974852 |
Device Name: | NON-PRESCRIPTION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | CHIA HUI SPECTACLES MFG. CORP. 10 FU CHIANG RD., SEC. 1, LANE 320 Yung Kang City, Tainan, Hsien, TW |
Contact | C A Chen |
Correspondent | C A Chen CHIA HUI SPECTACLES MFG. CORP. 10 FU CHIANG RD., SEC. 1, LANE 320 Yung Kang City, Tainan, Hsien, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-29 |
Decision Date | 1998-01-30 |