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FDA 510(k) Application Details - K173911
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K173911
Device Name
Dressing, Wound, Drug
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093 US
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Contact
Bethany Benoit-DiMaria
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
12/22/2017
Decision Date
07/19/2018
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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