Durex Condom with Benzocaine— 510(k) K211152

Name: FDA 510(k) clearance K211152
Creator: U.S. Food and Drug Administration
Published: 2022-05-11

Substantially Equivalent

Rb Health (Us), LLC

FDA 510(k) clearance K211152 for Durex Condom with Benzocaine, Substantially Equivalent on 2022-05-11. 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: 2021-04-19
Decision date: 2022-05-11
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.