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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 K033858
Device Name TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
Applicant
EUROPEAN CUSTOM MANUFACTURING BV
OOST-OM 54
NL-5422 VZ
GEMERT,  NL
Applicant Contact MAARTEN KANTERS
Correspondent
EUROPEAN CUSTOM MANUFACTURING BV
OOST-OM 54
NL-5422 VZ
GEMERT,  NL
Correspondent Contact MAARTEN KANTERS
Regulation Number870.3680
Classification Product Code
LDF  
Date Received12/11/2003
Decision Date 07/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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