L360 Thigh System— 510(k) K191587

Substantially Equivalent

Bioness, Inc.

FDA 510(k) clearance K191587 for L360 Thigh System, Substantially Equivalent on 2019-09-12. Applicant: Bioness, Inc..

Clearance details

Applicant: Bioness, Inc.
Product code: Code GZI
Advisory panel: Neurology
Date received: 2019-06-14
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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