FDA 510(k) Application Details - K110438

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K110438
Device Name Flowmeter, Blood, Cardiovascular
Applicant VASAMED, INC.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact Gary J Syring
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Regulation Number 870.2100

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Classification Product Code DPW
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Date Received 02/15/2011
Decision Date 05/04/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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