FDA 510(k) Application Details - K023016

Device Classification Name Device, Counter-Pulsating, External

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510(K) Number K023016
Device Name Device, Counter-Pulsating, External
Applicant NICORE EQUIPMENT & LEASING, INC.
4897 W. WATERS AVE., SUITE J
TAMPA, FL 33634 US
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Contact JEFF MOGILEWICZ
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Regulation Number 870.5225

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Classification Product Code DRN
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Date Received 09/10/2002
Decision Date 12/04/2002
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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