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FDA 510(k) Application Details - K202954
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K202954
Device Name
Mask, Surgical
Applicant
Xiamen Probtain Medical Techology Co., Ltd
4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District
Xiamen 361100 CN
Other 510(k) Applications for this Company
Contact
Jianli Kang
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
09/30/2020
Decision Date
07/02/2021
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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