The following data is part of a premarket notification filed by Eyeworks 3 with the FDA for Non-pres Sunglasses/spec Frames (plastic & Metal).
Device ID | K925736 |
510k Number | K925736 |
Device Name: | NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL) |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | EYEWORKS 3 7408 BEVERLY BLVD. Los Angeles, CA 90036 |
Contact | David P Duralde |
Correspondent | David P Duralde EYEWORKS 3 7408 BEVERLY BLVD. Los Angeles, CA 90036 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-13 |
Decision Date | 1993-06-28 |