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FDA 510(k) Application Details - K190224
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K190224
Device Name
Dressing, Wound, Drug
Applicant
Medline Industries, Inc.
Three Lake Drive
Northfield, IL 60093 US
Other 510(k) Applications for this Company
Contact
Claire Pigman
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
02/05/2019
Decision Date
03/08/2019
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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