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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
Applicant Contact JOSEPH M KONIECZNY
Correspondent
Harmac Medical Products, Inc.
2201 Bailey Ave.
Buffalo,  NY  14211
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
Predetermined Change
Control Plan Authorized		 No
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