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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K860922
Device Name MIKROS, MIKROS VS-1, PULSE GENERATOR
Applicant
Biotronik Sales, Inc.
Post Office Box 1988
Lake Oswego,  OR  97034
Applicant Contact CAWTHON, M.D.
Correspondent
Biotronik Sales, Inc.
Post Office Box 1988
Lake Oswego,  OR  97034
Correspondent Contact CAWTHON, M.D.
Regulation Number870.3610
Classification Product Code
DXY  
Date Received03/11/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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