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FDA 510(k) Application Details - K221532
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K221532
Device Name
Dressing, Wound, Drug
Applicant
Winner Medical Co., Ltd.
660 Bulong Road, Longhua District
Shenzhen CN
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Contact
Yi Fu
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
05/26/2022
Decision Date
01/30/2023
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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