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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K003551
Device Name VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
Applicant
JOSTRA AG
17511 ARMSTRONG AVE.
IRVINE,  CA  92614 -5686
Applicant Contact KATHLEEN JOHNSON
Correspondent
JOSTRA AG
17511 ARMSTRONG AVE.
IRVINE,  CA  92614 -5686
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received11/17/2000
Decision Date 07/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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