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FDA 510(k) Application Details - K202511
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K202511
Device Name
Mask, Surgical
Applicant
Improve Medical (HuNan) Co., Ltd.
No. 6, Yizhang East Avenue, Economic Development District
Yizhang 424200 CN
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Contact
Wang Jing
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
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More FDA Info for this Product Code
Date Received
08/31/2020
Decision Date
02/02/2021
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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