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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K912968
Device Name ELEC SURG INSTR FOR LOPPROSCOPE CHOLECYSTECYOMY
Applicant
Paden Foudry , Ltd.
C/Omcdonald & Gudmestad
906 Fourth Ave. P.O.Box 505
Windom,  MN  56101
Applicant Contact CHARLES A.PADEN
Correspondent
Paden Foudry , Ltd.
C/Omcdonald & Gudmestad
906 Fourth Ave. P.O.Box 505
Windom,  MN  56101
Correspondent Contact CHARLES A.PADEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/08/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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