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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reservoir, blood, cardiopulmonary bypass
510(k) Number K051606
Device Name GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
Applicant
GISH BIOMEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
GISH BIOMEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/16/2005
Decision Date 08/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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