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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, frozen donor tissue storage
510(K) Number K021702
Device Name CRYOBAG, MODEL CB
Applicant
ORIGEN BIOMEDICAL, INC.
9709-a beck circle
austin,  TX  78758
Contact richard martin
Classification Product Code
LPZ  
Date Received05/23/2002
Decision Date 08/06/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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