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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 K010281
Device Name MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.3680
Classification Product Code
DTB  
Date Received01/30/2001
Decision Date 04/09/2002
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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