FDA 510(k) Application Details - K131085

Device Classification Name

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510(K) Number K131085
Device Name CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
Applicant MESPERE LIFESCIENCES INC.
180 FROBISHER DR, UNIT 1C
WATERLOO, ON N2V 2A2 CA
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Contact HELEN TAN
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Regulation Number

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Classification Product Code PFA
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Date Received 04/18/2013
Decision Date 08/22/2013
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

FDA Source Information for K131085


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