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FDA 510(k) Application Details - K021702
Device Classification Name
Container, Frozen Donor Tissue Storage
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LPZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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