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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
Predetermined Change
Control Plan Authorized		 No
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