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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 K930716
Device Name LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION
Applicant
GABRIS SURGICAL CORP.
7 KESTER DR.
EDISON,  NJ  08817
Applicant Contact HOWARD K MANN
Correspondent
GABRIS SURGICAL CORP.
7 KESTER DR.
EDISON,  NJ  08817
Correspondent Contact HOWARD K MANN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/11/1993
Decision Date 07/23/1993
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
Predetermined Change
Control Plan Authorized		 No
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