BILLY BOY MALE LATEX CONDOM— 510(k) K111093

Substantially Equivalent

Mapa GmbH

FDA 510(k) clearance K111093 for BILLY BOY MALE LATEX CONDOM, Substantially Equivalent on 2011-06-03. Applicant: Mapa GmbH. Device class: 2.

Clearance details

Applicant: Mapa GmbH
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2011-04-19
Decision date: 2011-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zeven, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.