NervAlign Nerve Cuff— 510(k) K202234

Substantially Equivalent

Renerve, Ltd.

FDA 510(k) clearance K202234 for NervAlign Nerve Cuff, Substantially Equivalent on 2022-02-10. Applicant: Renerve, Ltd..

Clearance details

Applicant: Renerve, Ltd.
Product code: Code JXI
Advisory panel: Neurology
Date received: 2020-08-07
Decision date: 2022-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Melbourne, AU

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