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FDA 510(k) Application Details - K190129
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K190129
Device Name
Dressing, Wound, Drug
Applicant
Arch Therapeutics, Inc.
235 Walnut Street, suite 6
Framingham, MA 01702 US
Other 510(k) Applications for this Company
Contact
Terrence Norchi
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
01/28/2019
Decision Date
03/11/2020
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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