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FDA 510(k) Application Details - K963073
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K963073
Device Name
Electrode, Pacemaker, Temporary
Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO, NY 14211-1797 US
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Contact
JOSEPH M KONIECZNY
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
LDF
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More FDA Info for this Product Code
Date Received
06/28/1996
Decision Date
08/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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