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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 K011660
Device Name WECK CARDIAC PACING WIRES
Original Applicant
WECK CLOSURE SYSTEMS
one weck dr.
research triangle park,  NC  27709
Original Contact brian young
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/29/2001
Decision Date 08/21/2001
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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