Child Face Mask— 510(k) K201514

Name: FDA 510(k) clearance K201514
Creator: U.S. Food and Drug Administration
Published: 2021-10-10

Substantially Equivalent

Shandong Shengquan New Material Co., Ltd.

FDA 510(k) clearance K201514 for Child Face Mask, Substantially Equivalent on 2021-10-10. Applicant: Shandong Shengquan New Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Shengquan New Material Co., Ltd.
Product code: Code OXZ
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2020-06-08
Decision date: 2021-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinan, CN

Download summary PDF View on FDA.gov ↗

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