FDA 510(k) Application Details - K033617

Device Classification Name Device, Counter-Pulsating, External

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510(K) Number K033617
Device Name Device, Counter-Pulsating, External
Applicant VASOMEDICAL, INC.
180 LINDEN AVE.
WESTBURY, NY 11590 US
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Contact THOMAS R VARRICCHIONE
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Regulation Number 870.5225

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Classification Product Code DRN
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Date Received 11/18/2003
Decision Date 03/01/2004
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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