Surgical Gown— 510(k) K211077

Name: FDA 510(k) clearance K211077
Creator: U.S. Food and Drug Administration
Published: 2021-10-07

Substantially Equivalent

Wujiang Tutaike Textiles & Finishing Co., Ltd.

FDA 510(k) clearance K211077 for Surgical Gown, Substantially Equivalent on 2021-10-07. Applicant: Wujiang Tutaike Textiles & Finishing Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wujiang Tutaike Textiles & Finishing Co., Ltd.
Product code: Code FYA
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2021-04-12
Decision date: 2021-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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