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FDA 510(k) Application Details - K211552
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K211552
Device Name
Mask, Surgical
Applicant
Shandong Shengquan New Materials Co., Ltd.
Diaozhen Industrial Development Zone,
Zhangqiu District
Jinan 250204 CN
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Contact
Xiumei Zhang
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
05/19/2021
Decision Date
08/11/2021
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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