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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 K903928
Device Name LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
Applicant
BIOTRONIK, GMBH & CO.
6024 SOUTHWEST JEAN RD.
UNIT B4
LAKE OSWEGO,  OR  97035 -5369
Applicant Contact STOUT, MD
Correspondent
BIOTRONIK, GMBH & CO.
6024 SOUTHWEST JEAN RD.
UNIT B4
LAKE OSWEGO,  OR  97035 -5369
Correspondent Contact STOUT, MD
Regulation Number870.3680
Classification Product Code
DTB  
Date Received08/20/1990
Decision Date 10/16/1990
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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