The following data is part of a premarket notification filed by Atlantic Optical Co., Inc. with the FDA for Veneto Collection.
Device ID | K912034 |
510k Number | K912034 |
Device Name: | VENETO COLLECTION |
Classification | Frame, Spectacle |
Applicant | ATLANTIC OPTICAL CO., INC. 20801 NORDHOFF ST. P.O. BOX 3519 Chatsworth, CA 91313 |
Contact | Mel Hoffman |
Correspondent | Mel Hoffman ATLANTIC OPTICAL CO., INC. 20801 NORDHOFF ST. P.O. BOX 3519 Chatsworth, CA 91313 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-08 |
Decision Date | 1991-08-22 |