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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 K001520
FOIA Releasable 510(k) K001520
Device Name ALPHA OMEGA DUAL COOLER-HEATER
Applicant
Alpha Omega, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Applicant Contact RICHARD MARTIN
Correspondent
Alpha Omega, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Correspondent Contact RICHARD MARTIN
Regulation Number870.4250
Classification Product Code
DWC  
Date Received05/16/2000
Decision Date 11/22/2000
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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