Surgical Isolation Cover Gown— 510(k) K220528

Substantially Equivalent

Wuhan Dymex Healthcare Co., Ltd.

FDA 510(k) clearance K220528 for Surgical Isolation Cover Gown, Substantially Equivalent on 2022-06-10. Applicant: Wuhan Dymex Healthcare Co., Ltd..

Clearance details

Applicant: Wuhan Dymex Healthcare Co., Ltd.
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2022-02-24
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

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