The following data is part of a premarket notification filed by Marchon Eyewear, Inc. with the FDA for Marchon/marcolin Eyeglasses.
Device ID | K933733 |
510k Number | K933733 |
Device Name: | MARCHON/MARCOLIN EYEGLASSES |
Classification | Frame, Spectacle |
Applicant | MARCHON EYEWEAR, INC. 35 HUB DR. Melville, NY 11747 |
Contact | Joseph P Sherer |
Correspondent | Joseph P Sherer MARCHON EYEWEAR, INC. 35 HUB DR. Melville, NY 11747 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-02 |
Decision Date | 1993-10-01 |