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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name frame, spectacle
510(k) Number K933424
Device Name STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN
Applicant
ZYLOWARE CORP.
11-36 46TH RD.
long island city,  NY  11101
Applicant Contact thomas heckel
Correspondent
ZYLOWARE CORP.
11-36 46TH RD.
long island city,  NY  11101
Correspondent Contact thomas heckel
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/13/1993
Decision Date 09/20/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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