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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Sponge, Surgical
510(k) Number K873555
Device Name GORSK SPONGE CONTAINMENT SYSTEM
Applicant
Gorsk, Inc.
P.O. Box 398
Camarillo,  CA  93011
Applicant Contact NANCY G GORSKI
Correspondent
Gorsk, Inc.
P.O. Box 398
Camarillo,  CA  93011
Correspondent Contact NANCY G GORSKI
Regulation Number880.2740
Classification Product Code
LWH  
Date Received08/28/1987
Decision Date 10/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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