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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 K965106
Device Name ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact Joseph J Schwoebel
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact Joseph J Schwoebel
Regulation Number870.3680
Classification Product Code
DTB  
Date Received12/20/1996
Decision Date 01/27/1998
Decision SE SUBJECT TO TRAKING & PMS (PT)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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