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FDA 510(k) Application Details - K011660
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K011660
Device Name
Electrode, Pacemaker, Temporary
Applicant
WECK CLOSURE SYSTEMS
ONE WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact
BRIAN YOUNG
Other 510(k) Applications for this Contact
Regulation Number
870.3680
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Classification Product Code
LDF
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More FDA Info for this Product Code
Date Received
05/29/2001
Decision Date
08/21/2001
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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