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FDA 510(k) Application Details - K181074
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K181074
Device Name
Dressing, Wound, Drug
Applicant
Simple Science LLC
5555 W 78th St. STE M
Edina, MN 55439 US
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Contact
Eoin Croke
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
04/24/2018
Decision Date
08/17/2018
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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