Durex Patronus Wide— 510(k) K213647

Substantially Equivalent

Rb Health (Us), LLC

FDA 510(k) clearance K213647 for Durex Patronus Wide, Substantially Equivalent on 2022-02-17. Applicant: Rb Health (Us), LLC. Device class: 2.

Clearance details

Applicant: Rb Health (Us), LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2021-11-19
Decision date: 2022-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, 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.