ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500— 510(k) K162442

Substantially Equivalent

Gri Medical & Electrical Technology Co., Ltd.

FDA 510(k) clearance K162442 for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500, Substantially Equivalent on 2016-12-12. 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: 2016-08-31
Decision date: 2016-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

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