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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K853568
Device Name DNR UNIPOLAR
Applicant
BIOTRONIK SALES, INC.
POST OFFICE BOX 1988
LAKE OSWEGO,  OR  97034
Applicant Contact JUERGEN M BAHR
Correspondent
BIOTRONIK SALES, INC.
POST OFFICE BOX 1988
LAKE OSWEGO,  OR  97034
Correspondent Contact JUERGEN M BAHR
Regulation Number870.3680
Classification Product Code
DTB  
Date Received08/26/1985
Decision Date 01/15/1986
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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