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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 K945720
Device Name JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
Applicant
Jostra Bentley
2525 Hartford Rd.
Austin,  TX  78703
Applicant Contact RICHARD MARTIN
Correspondent
Jostra Bentley
2525 Hartford Rd.
Austin,  TX  78703
Correspondent Contact RICHARD MARTIN
Regulation Number870.4250
Classification Product Code
DWC  
Date Received11/21/1994
Decision Date 03/29/1995
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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