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FDA 510(k) Application Details - K082869
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K082869
Device Name
Dressing, Wound, Collagen
Applicant
AUBREY, INC.
5930 SEA LION PLACE
CARLSBAD, CA 92010 US
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Contact
STEPHEN MOSS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2008
Decision Date
02/06/2009
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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