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FDA 510(k) Application Details - K213970
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K213970
Device Name
Mask, Surgical
Applicant
Danameco Medical Joint Stock Corporation
No 12, Trinh Cong Son Street
Da Nang 550000 VN
Other 510(k) Applications for this Company
Contact
Huynh Thi Li 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
12/20/2021
Decision Date
01/23/2022
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
Y
Expedited Review
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