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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K941500
Device Name TISSUE ISOLATION AND RETRIEVAL BAG
Applicant
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact HOWARD SHRAYER
Correspondent
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact HOWARD SHRAYER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/29/1994
Decision Date 04/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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