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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K030077
Device Name GISH TUBING AND CONNECTORS 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 Number870.4290
Classification Product Code
DTL  
Subsequent Product Code
DWF  
Date Received01/08/2003
Decision Date 03/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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