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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 K031210
Device Name MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
Applicant
Metronic, Inc.
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact TINA BENOIT
Correspondent
Metronic, Inc.
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact TINA BENOIT
Regulation Number870.3680
Classification Product Code
DTB  
Date Received04/17/2003
Decision Date 05/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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