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FDA 510(k) Application Details - K101114
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K101114
Device Name
Dressing, Wound, Drug
Applicant
Advancis Medical
Sidings Road, Lowmoor Industrial Estate
Kirby in Ashfield NG17 7JZ GB
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Contact
Toni Miller
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2010
Decision Date
07/26/2011
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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