FDA 510(k) Application Details - K151776

Device Classification Name

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510(K) Number K151776
Device Name Central Venous Pressure System
Applicant Mespere LifeSciences Inc.
180 Frobisher Dr, Unit 1C
Waterloo, ON N2V2A2 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 07/01/2015
Decision Date 08/12/2015
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

FDA Source Information for K151776


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