The following data is part of a premarket notification filed by Atlantic Optical Co., Inc. with the FDA for Eyeglass Spectacle Frames Various Collections.
Device ID | K941052 |
510k Number | K941052 |
Device Name: | EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS |
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 | 1994-03-03 |
Decision Date | 1994-04-12 |