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FDA 510(k) Application Details - K210015
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K210015
Device Name
Mask, Surgical
Applicant
Sample King Manufacturing Ltd
Southwest side of the intersection of Mingzhu Boulevard and
Shenyan Road, Yantian District
Shenzhen 518083 CN
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Contact
Forest Cao
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
01/04/2021
Decision Date
06/10/2021
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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