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FDA 510(k) Application Details - K222456
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K222456
Device Name
Gown, Surgical
Applicant
3A Medical Products Co., Ltd
Yuan Industrial Park
Liuan 237100 CN
Other 510(k) Applications for this Company
Contact
Amy Ma
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2022
Decision Date
03/12/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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