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FDA 510(k) Application Details - K201138
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K201138
Device Name
Dressing, Wound, Drug
Applicant
Amsino Medical Inc.
700 Enterprise St. Aurora
Aurora, IL 60504 US
Other 510(k) Applications for this Company
Contact
Torsten Nilson
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
04/28/2020
Decision Date
04/14/2021
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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