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FDA 510(k) Application Details - K203524
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K203524
Device Name
Mask, Surgical
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
No.10 Juncheng Road, Eastern Area,
E&T Development District, Guangzhou, China
Guangzhou 510760 CN
Other 510(k) Applications for this Company
Contact
Mu Fanzhen
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2020
Decision Date
02/25/2021
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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