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FDA 510(k) Application Details - K163062
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K163062
Device Name
Dressing, Wound, Drug
Applicant
Advanced Medical Solutions Ltd.
Premier Park, 33 Road One, Winsford Industrial Estate
Winsford CW7 3RT GB
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Contact
Kay McGrath
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
11/02/2016
Decision Date
07/25/2017
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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