LATEX CONDOMS (NATURAL COLOUR)— 510(k) K974326

Name: FDA 510(k) clearance K974326
Creator: U.S. Food and Drug Administration
Published: 1998-02-09

Substantially Equivalent

Reddy Medtech Health Products , Ltd.

FDA 510(k) clearance K974326 for LATEX CONDOMS (NATURAL COLOUR), Substantially Equivalent on 1998-02-09. Applicant: Reddy Medtech Health Products , Ltd.. Device class: 2.

Clearance details

Applicant: Reddy Medtech Health Products , Ltd.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1997-11-18
Decision date: 1998-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainsboro, NJ, US

Download summary PDF View on FDA.gov ↗

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