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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 K943671
Device Name GSI CANNULA REDUCER ACCESSORY
Applicant
GENERAL SURGICAL INNOVATIONS
3280 ALPINE RD.
PORTOLA VALLEY,  CA  94028
Applicant Contact THOMAS J FOGARTY
Correspondent
GENERAL SURGICAL INNOVATIONS
3280 ALPINE RD.
PORTOLA VALLEY,  CA  94028
Correspondent Contact THOMAS J FOGARTY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/26/1994
Decision Date 08/09/1994
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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