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FDA 510(k) Application Details - K142592
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K142592
Device Name
Dressing, Wound, Drug
Applicant
SIMPLE SCIENCE, LLC
530 NORTH 3RD STREET
SUITE 310
MINNEAPOLIS, MN 55401 US
Other 510(k) Applications for this Company
Contact
Justin Scanlan
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
09/15/2014
Decision Date
09/02/2015
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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