Disposable Surgical Gown— 510(k) K212591

Substantially Equivalent

Suzhou Janee Medical Technology Co., Ltd.

FDA 510(k) clearance K212591 for Disposable Surgical Gown, Substantially Equivalent on 2022-01-11. Applicant: Suzhou Janee Medical Technology Co., Ltd..

Clearance details

Applicant: Suzhou Janee Medical Technology Co., Ltd.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2021-08-16
Decision date: 2022-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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