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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, pacemaker, temporary
510(k) Number K963073
Device Name HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
Original Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 bailey ave.
buffalo,  NY  14211 1797
Original Contact joseph m konieczny
Regulation Number870.3680
Classification Product Code
LDF  
Date Received06/28/1996
Decision Date 08/14/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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