GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS— 510(k) K111458

Name: FDA 510(k) clearance K111458
Creator: U.S. Food and Drug Administration
Published: 2011-12-01

Substantially Equivalent

Gri Medical & Electronic Technology Co., Ltd.

FDA 510(k) clearance K111458 for GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS, Substantially Equivalent on 2011-12-01. Applicant: Gri Medical & Electronic Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gri Medical & Electronic Technology Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2011-05-26
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swanee, GA, US

Download summary PDF View on FDA.gov ↗

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