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FDA 510(k) Application Details - K222426
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K222426
Device Name
Mask, Surgical
Applicant
Phu Bao Group Company Limited
5 floor, CJ Building, 02Bis-4-6 Le Thanh Ton Street
Ben Nghe Ward, District 1
Ho Chi Minh 70000 VN
Other 510(k) Applications for this Company
Contact
Le Pham Minh Ngoc
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
08/11/2022
Decision Date
09/02/2022
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
Y
Expedited Review
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