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FDA 510(k) Application Details - K080868
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K080868
Device Name
Dressing, Wound, Collagen
Applicant
AEON ASTRON EUROPE B.V.
NIELS BOHRWEG 11-13
LEIDEN 2333 NL
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Contact
HORNG J LAI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
03/28/2008
Decision Date
05/14/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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