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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 K870269
Device Name ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
Applicant
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/23/1987
Decision Date 03/09/1987
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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