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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K142598
Device Name Opto Wire and OptoMonitor System
Applicant
Opsens, Inc.
2014 Rue Cyrille Duquet, #125
Quebec,  CA G1N 4N6
Applicant Contact Vanessa Mootoosamy
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received09/15/2014
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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