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510(k) K202719

Disposable Medical Face Masks by Jiangxi Sanxin Medtec Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2021
Date Received
September 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Jiangxi Sanxin Medtec Co., Ltd.

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