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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 K932540
Device Name LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE
Applicant
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact ANGELIQUE ANDERSON
Correspondent
ADVANCED SURGICAL, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact ANGELIQUE ANDERSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/26/1993
Decision Date 02/17/1994
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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