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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 K022321
Device Name STOCKERT V172-28 VENOUS FEMORAL CANNULA
Applicant
STOCKERT INSTRUMENTE GMBH
14401 W. 65th Way
Arvada,  CO  80004 -3599
Applicant Contact SHAWN RIEDEL
Correspondent
STOCKERT INSTRUMENTE GMBH
14401 W. 65th Way
Arvada,  CO  80004 -3599
Correspondent Contact SHAWN RIEDEL
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/17/2002
Decision Date 10/09/2002
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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