RIA LATEX CONDOM, NONOXYNOL-9— 510(k) K945145

Name: FDA 510(k) clearance K945145
Creator: U.S. Food and Drug Administration
Published: 1996-02-21

Substantially Equivalent

Mbf Personal Care Sdn. Bhd.

FDA 510(k) clearance K945145 for RIA LATEX CONDOM, NONOXYNOL-9, Substantially Equivalent on 1996-02-21. Applicant: Mbf Personal Care Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Mbf Personal Care Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1994-10-20
Decision date: 1996-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Senai, Johor, MY

Download summary PDF View on FDA.gov ↗

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