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FDA 510(k) Application Details - K181423
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K181423
Device Name
Dressing, Wound, Drug
Applicant
Amsino International Inc.
708 Corporate Center Drive
Pomona, CA 91768 US
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Contact
Jane Gao
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
05/31/2018
Decision Date
09/07/2018
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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