Leva Pelvic Health System— 510(k) K212495

Substantially Equivalent

Renovia, Inc.

FDA 510(k) clearance K212495 for Leva Pelvic Health System, Substantially Equivalent on 2021-09-08. Applicant: Renovia, Inc..

Clearance details

Applicant: Renovia, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-09
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

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