EPIGUARD— 510(k) K050188

Substantially Equivalent

Episafe Medical Devices, Ltd.

FDA 510(k) clearance K050188 for EPIGUARD, Substantially Equivalent on 2005-04-27. Applicant: Episafe Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Episafe Medical Devices, Ltd.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 2005-01-27
Decision date: 2005-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, MA, 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.