FDA 510(k) Application Details - K033657

Device Classification Name Device, Counter-Pulsating, External

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510(K) Number K033657
Device Name Device, Counter-Pulsating, External
Applicant LIVING DATA TECHNOLOGIES CORPORATION
55 NORTHERN BLVD. SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 870.5225

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Classification Product Code DRN
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Date Received 11/21/2003
Decision Date 12/19/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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