ComfortGuard Surgical Gown, i600, Film Reinforced— 510(k) K163191

Substantially Equivalent

Gri Medical & Electrical Technology Co., Ltd.

FDA 510(k) clearance K163191 for ComfortGuard Surgical Gown, i600, Film Reinforced, Substantially Equivalent on 2017-02-27. Applicant: Gri Medical & Electrical Technology Co., Ltd..

Clearance details

Applicant: Gri Medical & Electrical Technology Co., Ltd.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2016-11-14
Decision date: 2017-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

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