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FDA 510(k) Application Details - K123756
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K123756
Device Name
Dressing, Wound, Collagen
Applicant
COVALON TECHNOLOGIES LTD.
405 BRITANNIA ROAD EAST
SUITE 106
MISSISSAUGA, ONTARIO L4Z 3E6 CA
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Contact
CHRISTOPHER FREDRIC
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
12/07/2012
Decision Date
08/16/2013
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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