K-number	K212495
Device name	Leva Pelvic Health System
Applicant	Renovia, Inc.
Product code	HIR
Device class	Class II
Decision date	Sep 8, 2021
Decision	Substantially Equivalent
Regulation	884.1425

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Source

View the full FDA submission: accessdata.fda.gov

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Leva Pelvic Health System

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