Kangbeier Child Surgical Mask— 510(k) K221753

Name: FDA 510(k) clearance K221753
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Substantially Equivalent

Xinxiang Kangbeier Medical Technology Co., Ltd.

FDA 510(k) clearance K221753 for Kangbeier Child Surgical Mask, Substantially Equivalent on 2023-12-21. Applicant: Xinxiang Kangbeier Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xinxiang Kangbeier Medical Technology Co., Ltd.
Product code: Code OXZ
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2022-06-16
Decision date: 2023-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changyuan, CN

Download summary PDF View on FDA.gov ↗

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