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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K031544
FOIA Releasable 510(k) K031544
Device Name HEATER COOLER UNIT, MODEL HCU 30
Applicant
Jostra AB
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Applicant Contact LE ANN LATHAM
Correspondent
Jostra AB
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Correspondent Contact LE ANN LATHAM
Regulation Number870.4250
Classification Product Code
DWC  
Date Received05/16/2003
Decision Date 08/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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