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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 K863879
Device Name NEOS-M VS-1 PULSE GENERATOR
Applicant
BIOTRONIK SALES, INC.
POST OFFICE BOX 1988
LAKE OSWEGO,  OR  97034
Applicant Contact KEVIN S HEGGS
Correspondent
BIOTRONIK SALES, INC.
POST OFFICE BOX 1988
LAKE OSWEGO,  OR  97034
Correspondent Contact KEVIN S HEGGS
Regulation Number870.3610
Classification Product Code
DXY  
Date Received10/06/1986
Decision Date 12/10/1986
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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