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FDA 510(k) Application Details - K002481
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K002481
Device Name
Electrode, Pacemaker, Temporary
Applicant
ZCV ,INC.
298 FERNWOOD AVE.
EDISON, NJ 08837 US
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Contact
JING ZHANG
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
LDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/14/2000
Decision Date
12/07/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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