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FDA 510(k) Application Details - K223526
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K223526
Device Name
Dressing, Wound, Drug
Applicant
Smith & Nephew Medical Limited
101 Hessle Road
Hull HU3 2BN GB
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Contact
Hannah Sharp
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
11/23/2022
Decision Date
08/18/2023
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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