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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K884404
Device Name HERNIASTAT
Applicant
INNOVATIVE SURGICAL DEVICES CORP.
694 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact ROBERT R ODDSEN
Correspondent
INNOVATIVE SURGICAL DEVICES CORP.
694 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact ROBERT R ODDSEN
Regulation Number878.4740
Classification Product Code
GAG  
Date Received10/19/1988
Decision Date 11/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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