The following data is part of a premarket notification filed by Evergreat Optical Ind Co., Ltd. with the FDA for Nil.
Device ID | K940846 |
510k Number | K940846 |
Device Name: | NIL |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EVERGREAT OPTICAL IND CO., LTD. P.O. BOX 44-101 Taipei, Taiwan, TW |
Contact | Tonya S.t. Chow |
Correspondent | Tonya S.t. Chow EVERGREAT OPTICAL IND CO., LTD. P.O. BOX 44-101 Taipei, Taiwan, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-23 |
Decision Date | 1994-04-12 |