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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K830511
Device Name ZANLEX, ZAN-TEX & ZANDEX
Applicant
Winn Hirsch & Assoc.
30 Sylvia Rd.
Plainview,  NY  11803
Applicant Contact WIN HIRSCH
Correspondent
Winn Hirsch & Assoc.
30 Sylvia Rd.
Plainview,  NY  11803
Correspondent Contact WIN HIRSCH
Regulation Number878.4450
Classification Product Code
GDY  
Date Received02/17/1983
Decision Date 03/17/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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