The following data is part of a premarket notification filed by Ever Great International Ltd. with the FDA for Nil.
Device ID | K942755 |
510k Number | K942755 |
Device Name: | NIL |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EVER GREAT INTERNATIONAL LTD. P.O. BOX 44-101 Taipei, TW |
Contact | Tony S T. Chow |
Correspondent | Tony S T. Chow EVER GREAT INTERNATIONAL LTD. P.O. BOX 44-101 Taipei, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-10 |
Decision Date | 1994-07-25 |