FDA 510(k) Application Details - K962467

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K962467
Device Name Electrode, Pacemaker, Temporary
Applicant ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3537 US
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Contact DAVE GUZEK
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 06/25/1996
Decision Date 09/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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