SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED— 510(k) K993779

Name: FDA 510(k) clearance K993779
Creator: U.S. Food and Drug Administration
Published: 2000-02-02

Substantially Equivalent

P.T. Vonix Latexindo Condom (Rubber) Mfg.

FDA 510(k) clearance K993779 for SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED, Substantially Equivalent on 2000-02-02. Applicant: P.T. Vonix Latexindo Condom (Rubber) Mfg.. Device class: 2.

Clearance details

Applicant: P.T. Vonix Latexindo Condom (Rubber) Mfg.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-08
Decision date: 2000-02-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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