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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K082403
Device Name MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
Applicant
GISH BIOMEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact HARVEY KNAUSS
Correspondent
GISH BIOMEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact HARVEY KNAUSS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received08/21/2008
Decision Date 05/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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