FDA 510(k) Application Details - K021702

Device Classification Name Container, Frozen Donor Tissue Storage

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510(K) Number K021702
Device Name Container, Frozen Donor Tissue Storage
Applicant ORIGEN BIOMEDICAL, INC.
9709-A BECK CIRCLE
AUSTIN, TX 78758 US
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Contact RICHARD MARTIN
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Regulation Number 000.0000

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Classification Product Code LPZ
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Date Received 05/23/2002
Decision Date 08/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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