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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 K921287
Device Name SURGICAL RETRACTOR
Applicant
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact Howard Schrayer
Correspondent
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact Howard Schrayer
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/17/1992
Decision Date 03/04/1993
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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