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510(k) K222483

Surgical Face Mask by Hubei Woozon Healthcare Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2023
Date Received
August 17, 2022
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 Hubei Woozon Healthcare Co., Ltd.

  • K222999 — Surgical Gown (June 16, 2023)

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  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
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