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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
Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Applicant Contact JOSEPH M KONIECZNY
Correspondent
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Correspondent Contact JOSEPH M KONIECZNY
Regulation Number870.3680
Classification Product Code
LDF  
Date Received06/28/1996
Decision Date 08/14/1997
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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