The following data is part of a premarket notification filed by Zyloware Corp. with the FDA for Stetson/s.loren/h.bazaar/g.vanderbilt/p.balmain.
Device ID | K933424 |
510k Number | K933424 |
Device Name: | STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN |
Classification | Frame, Spectacle |
Applicant | ZYLOWARE CORP. 11-36 46TH RD. Long Island City, NY 11101 |
Contact | Thomas Heckel |
Correspondent | Thomas Heckel ZYLOWARE CORP. 11-36 46TH RD. Long Island City, NY 11101 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-13 |
Decision Date | 1993-09-20 |