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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubing, pump, cardiopulmonary bypass
510(k) Number K053025
Device Name JOSTRA HLM TUBING SET
Applicant
MAQUET CARDIOPULMONARY AG
P.O. BOX 2042
FAIRFIELD,  IA  52556
Applicant Contact KATHLEEN JOHNSON
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number870.4390
Classification Product Code
DWE  
Date Received10/27/2005
Decision Date 11/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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