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FDA 510(k) Application Details - K214087
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K214087
Device Name
Mask, Surgical
Applicant
Hubei Medlink Healthcare Co., Ltd
36F, Tower1, New World International Trade Tower
568 Jianshe Avenue
Wuhan 430000 CN
Other 510(k) Applications for this Company
Contact
Sophie Liu
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
12/27/2021
Decision Date
03/08/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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