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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
Applicant Contact RICHARD MARTIN
Correspondent
Origen Biomedical, Inc.
9709-A Beck Circle
Austin,  TX  78758
Correspondent Contact RICHARD MARTIN
Classification Product Code
LPZ  
Date Received05/23/2002
Decision Date 08/06/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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