The following data is part of a premarket notification filed by Eva Optiks, Inc. with the FDA for Western Trading Co.
Device ID | K941047 |
510k Number | K941047 |
Device Name: | WESTERN TRADING CO |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EVA OPTIKS, INC. P.O. BOX 987. Kaohsiung, Taiwan, TW |
Contact | Basil Lin |
Correspondent | Basil Lin EVA OPTIKS, INC. P.O. BOX 987. Kaohsiung, 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 | 1994-03-07 |
Decision Date | 1994-07-12 |