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FDA 510(k) Application Details - K131085
Device Classification Name
More FDA Info for this Device
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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