COOLSKIN— 510(k) K083008

Substantially Equivalent

Elbio Co., Ltd.

FDA 510(k) clearance K083008 for COOLSKIN, Substantially Equivalent on 2009-06-10. Applicant: Elbio Co., Ltd.. Device class: 2.

Clearance details

Applicant: Elbio Co., Ltd.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 2008-10-08
Decision date: 2009-06-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.