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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K092644
Device Name TERUMO PRESSURE ISOLATOR
Applicant
Terumo Cardiovascular Systems Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact GARRY A COURTNEY
Correspondent
Terumo Cardiovascular Systems Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact GARRY A COURTNEY
Regulation Number870.2850
Classification Product Code
DRS  
Date Received08/27/2009
Decision Date 12/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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