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510(k) K222545

Disposable Medical Mask by Guangzhou Fuzelong Hygiene Material Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
August 22, 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 Guangzhou Fuzelong Hygiene Material Co., Ltd.

  • K222403 — Surgical Gown (January 26, 2023)

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