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FDA 510(k) Application Details - K153674
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K153674
Device Name
Dressing, Wound, Drug
Applicant
ABIGO Medical AB
Ekonomivagen 5
Askim SE-43633 SE
Other 510(k) Applications for this Company
Contact
Annica Corbe
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
12/21/2015
Decision Date
07/01/2016
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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