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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 K875199
Device Name NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
Applicant
Biotronik Sales, Inc.
P.O. Box 1988
Lake Oswego,  OR  97035
Applicant Contact RICHARD STOUT
Correspondent
Biotronik Sales, Inc.
P.O. Box 1988
Lake Oswego,  OR  97035
Correspondent Contact RICHARD STOUT
Regulation Number870.3680
Classification Product Code
DTB  
Date Received12/18/1987
Decision Date 02/18/1988
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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