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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 K050195
Device Name V-BAG WITH GBS COATING
Original Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston,  TX  77071
Original Contact j. harvey knauss
Regulation Number870.4400
Classification Product Code
DTN  
Date Received01/27/2005
Decision Date 03/17/2005
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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