DUREX LUBRAGEL LATEX CONDOM— 510(k) K983380

Substantially Equivalent

London Intl., LLC

FDA 510(k) clearance K983380 for DUREX LUBRAGEL LATEX CONDOM, Substantially Equivalent on 1998-11-16. Applicant: London Intl., LLC. Device class: 2.

Clearance details

Applicant: London Intl., LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-25
Decision date: 1998-11-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

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More clearances from London Intl., LLC

K982924 — DUREX SENSIDOM LATEX CONDOM1998-11-16
K980174 — DUREX COLORS AND SCENTS1998-08-13
K980785 — STERILE, POWDERFREE LATEX EXAMINATION GLOVE1998-06-10
K980319 — DUREX ULTRA COMFORT1998-05-20
K980204 — DUREX LATEX CONDOMS1998-04-17

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