LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)— 510(k) K942858

Name: FDA 510(k) clearance K942858
Creator: U.S. Food and Drug Administration
Published: 1995-05-18

Substantially Equivalent

Suretex, Ltd.

FDA 510(k) clearance K942858 for LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9), Substantially Equivalent on 1995-05-18. Applicant: Suretex, Ltd.. Device class: 2.

Clearance details

Applicant: Suretex, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-16
Decision date: 1995-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thailand, TH

Download summary PDF View on FDA.gov ↗

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