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FDA 510(k) Application Details - K152926
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K152926
Device Name
Dressing, Wound, Drug
Applicant
CONVATEC LIMITED
FIRST AVENUE, DEESIDE INDUSTRIAL PARK
DEESIDE CH5 2NU GB
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Contact
AARON SIBLEY
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
10/05/2015
Decision Date
01/21/2016
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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