TROJAN EXTRA LARGE LATEX CONDOM— 510(k) K001212

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K001212 for TROJAN EXTRA LARGE LATEX CONDOM, Substantially Equivalent on 2000-05-09. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2000-04-14
Decision date: 2000-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Cranbury, 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.