Disposable Surgical Gown— 510(k) K212925

Substantially Equivalent

Henan Robestain Medical Products Co., Ltd.

FDA 510(k) clearance K212925 for Disposable Surgical Gown, Substantially Equivalent on 2021-12-13. Applicant: Henan Robestain Medical Products Co., Ltd..

Clearance details

Applicant: Henan Robestain Medical Products Co., Ltd.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2021-09-14
Decision date: 2021-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changyuan, CN

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