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FDA 510(k) Application Details - K172399
Device Classification Name
Dressing, Wound, Collagen
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510(K) Number
K172399
Device Name
Dressing, Wound, Collagen
Applicant
ACell, Inc.
6640 Eli Whitney Drive, Suite 200
Columbia, MD 21046 US
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Contact
Salman Elmi
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
08/08/2017
Decision Date
10/06/2017
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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