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FDA 510(k) Application Details - K221110
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K221110
Device Name
Dressing, Wound, Drug
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd, Dongjiang Hi-tech Industrial Park
Huizhou 516005 CN
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Contact
Jie Dong
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
04/15/2022
Decision Date
01/04/2024
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
FDA Source Information for K221110
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