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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 K013944
Device Name JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
Applicant
JOSTRA AG
478 MEDIA RD.
OXFORD,  PA  19363
Applicant Contact KATHLEEN JOHNSON
Correspondent
JOSTRA AG
478 MEDIA RD.
OXFORD,  PA  19363
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
Subsequent Product Code
DTL  
Date Received11/29/2001
Decision Date 02/11/2002
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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