The following data is part of a premarket notification filed by Great Field Industries Co., Ltd. with the FDA for Sunglasses.
Device ID | K944568 |
510k Number | K944568 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | GREAT FIELD INDUSTRIES CO., LTD. 1 FL., NO.109, MIN CHUAN RD. Hsin Tien City, Taipei Hsien, TW |
Contact | Jerry Chao |
Correspondent | Jerry Chao GREAT FIELD INDUSTRIES CO., LTD. 1 FL., NO.109, MIN CHUAN RD. Hsin Tien City, Taipei 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 | 1994-09-19 |
Decision Date | 1995-01-09 |