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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K142500
Device Name One Way Soft Valve
Applicant
Terumo Cardiovascular Systems Corporation
28 Howe St.
Ashland,  MA  01721
Applicant Contact Suzanne Grenier
Correspondent
Terumo Cardiovascular Systems Corporation
28 Howe St.
Ashland,  MA  01721
Correspondent Contact Suzanne Grenier
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received09/05/2014
Decision Date 01/29/2015
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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