The following data is part of a premarket notification filed by Jane Fui Optical Co., Ltd. with the FDA for Acrylic Reading And Polycarbonate Lenses Sunglasses.
Device ID | K962279 |
510k Number | K962279 |
Device Name: | ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | JANE FUI OPTICAL CO., LTD. 7 SHIN HO RD. AN PIN INDUSTRIAL DISTRICT Tainan, TW |
Contact | James Wu |
Correspondent | James Wu JANE FUI OPTICAL CO., LTD. 7 SHIN HO RD. AN PIN INDUSTRIAL DISTRICT Tainan, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-13 |
Decision Date | 1996-08-26 |