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510(k) K003371

PUMP TUBING WITH X-COATING by Terumo Corp. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2000
Date Received
October 30, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

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