CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX— 510(k) K003375

Name: FDA 510(k) clearance K003375
Creator: U.S. Food and Drug Administration
Published: 2001-01-28

Substantially Equivalent

Tecnilatex S.A.

FDA 510(k) clearance K003375 for CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX, Substantially Equivalent on 2001-01-28. Applicant: Tecnilatex S.A.. Device class: 2.

Clearance details

Applicant: Tecnilatex S.A.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 2000-10-30
Decision date: 2001-01-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Madrid, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code LTZ

view all

K033163 — CAUTION CONDOMS2004-04-27
K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM2002-06-12
K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM2001-04-27
K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-92000-08-08
K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM2000-06-08

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