Comfort Gown, Safewear Gown— 510(k) K213893

Substantially Equivalent

Xuchang Zhengde Environstar Medical Products Co., Ltd.

FDA 510(k) clearance K213893 for Comfort Gown, Safewear Gown, Substantially Equivalent on 2022-12-21. Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd..

Clearance details

Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2021-12-14
Decision date: 2022-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xuchang, CN

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