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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 K002603
Device Name ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
Applicant
ZCV ,INC.
298 FERNWOOD AVE.
EDISON,  NJ  08837
Applicant Contact JING ZHANG
Correspondent
ZCV ,INC.
298 FERNWOOD AVE.
EDISON,  NJ  08837
Correspondent Contact JING ZHANG
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/22/2000
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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