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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K023056
Device Name CIRCUIT TUBINGS WITH X-COATING
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact KAZUHITO INOUE
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact KAZUHITO INOUE
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/13/2002
Decision Date 11/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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