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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 K002481
Device Name ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
Original Applicant
ZCV ,INC.
298 fernwood ave.
edison,  NJ  08837
Original Contact jing zhang
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/14/2000
Decision Date 12/07/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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