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FDA 510(k) Application Details - K112409
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K112409
Device Name
Dressing, Wound, Collagen
Applicant
ACELL, INC
6640 ELI WHITNEY DRIVE
SUITE 200
COLUMBIA, MD 21046 US
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Contact
DEBORAH A BAKER-JANIS
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
08/22/2011
Decision Date
08/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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