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FDA 510(k) Application Details - K130781
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K130781
Device Name
Dressing, Wound, Drug
Applicant
GLYCOBIOSCIENCES, INC
181 LAKESHORE ROAD EAST
MISSISSAUGA, ONTARIO L5G 1G2 CA
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OLUFEMI ADEOYE
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Regulation Number
000.0000
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Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
03/21/2013
Decision Date
02/14/2014
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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