EXTACISER PERINEAL MUSCLE EXERCISER— 510(k) K892888

Name: FDA 510(k) clearance K892888
Creator: U.S. Food and Drug Administration
Published: 1989-10-05

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K892888 for EXTACISER PERINEAL MUSCLE EXERCISER, Substantially Equivalent on 1989-10-05. Applicant: Bivona Medical Technologies. Device class: 2.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1989-04-20
Decision date: 1989-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, 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.