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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-invasive central venous manometer
510(k) Number K131085
Device Name CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
Applicant
MESPERE LIFESCIENCES INC.
180 FROBISHER DR, UNIT 1C
WATERLOO, ON,  CA N2V 2A2
Applicant Contact HELEN TAN
Correspondent
MESPERE LIFESCIENCES INC.
180 FROBISHER DR, UNIT 1C
WATERLOO, ON,  CA N2V 2A2
Correspondent Contact HELEN TAN
Regulation Number870.1140
Classification Product Code
PFA  
Date Received04/18/2013
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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