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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 K020784
Device Name JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
Original Applicant
JOSTRA AG
p.o. box 218
oxford,  PA  19363
Original Contact kathleen johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/11/2002
Decision Date 01/09/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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