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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K851121
Device Name PI-PHEUMO INTESTINAL INSTRUMENT SET
Applicant
Surgeons Choice, Inc.
Baker & Mckenzie
815 Connecticut Ave. NW
Washington,  DC  20006
Applicant Contact DAVID B VANCE
Correspondent
Surgeons Choice, Inc.
Baker & Mckenzie
815 Connecticut Ave. NW
Washington,  DC  20006
Correspondent Contact DAVID B VANCE
Regulation Number878.4740
Classification Product Code
GAG  
Date Received03/19/1985
Decision Date 04/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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