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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 K023251
Device Name PEDIATRIC ARTERIAL CANNULA
Original Applicant
POLYSTAN A/S
walgerholm 8
vaerlose,  DA dk-3500
Original Contact dana olsen
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/30/2002
Decision Date 12/04/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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