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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 K940193
Device Name SURGICAL RETRACTOR KIT
Applicant
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact ANGELIQUE LAYTON ANDERSON
Correspondent
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact ANGELIQUE LAYTON ANDERSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/13/1994
Decision Date 02/15/1994
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
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