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FDA 510(k) Application Details - K203775
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K203775
Device Name
Mask, Surgical
Applicant
The Aleen International Corporation
Jiutian Green Science and Technology Industrial Park,
Heyuan High-Tech Zone
Heyuan 517000 CN
Other 510(k) Applications for this Company
Contact
Can Huang
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
12/28/2020
Decision Date
03/12/2021
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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