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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 K962833
Device Name HARMAC TEMPORARY PACING CATHETER WITH BALLOON
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 10/15/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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