Home / 510(k) Clearances / K202697

510(k) K202697

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask by United Sewing Automation, Inc. — Product Code FXX

K202697 is an FDA 510(k) premarket notification submitted by United Sewing Automation, Inc. for the device "United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask". The FDA issued a decision of Substantially Equivalent on May 13, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2021
Date Received
Sep 16, 2020
Clearance Type
Abbreviated
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
510(k)

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FDA data resources