FDA 510(k) Application Details - K033424

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K033424
Device Name Flowmeter, Blood, Cardiovascular
Applicant TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA, NY 14850 US
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Contact MARK S ALSBERGE
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Regulation Number 870.2100

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Classification Product Code DPW
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Date Received 10/23/2003
Decision Date 12/11/2003
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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