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FDA 510(k) Application Details - K210380
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K210380
Device Name
Mask, Surgical
Applicant
Shantou T&K Medical Equipment Factory Co.,Ltd
No.8 Workshop, Wanji South Second Street
Shantou 515065 CN
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Contact
Wan Li
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
02/09/2021
Decision Date
07/08/2021
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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