SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331— 510(k) K100382

Name: FDA 510(k) clearance K100382
Creator: U.S. Food and Drug Administration
Published: 2010-08-05

Substantially Equivalent

Salumedica, LLC

FDA 510(k) clearance K100382 for SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331, Substantially Equivalent on 2010-08-05. Applicant: Salumedica, LLC. Device class: 2.

Clearance details

Applicant: Salumedica, LLC
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2010-02-16
Decision date: 2010-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, 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.