HTL MALE CONDOM— 510(k) K980019

Name: FDA 510(k) clearance K980019
Creator: U.S. Food and Drug Administration
Published: 1998-04-01

Substantially Equivalent

Reddy Medtech Health Products , Ltd.

FDA 510(k) clearance K980019 for HTL MALE CONDOM, Substantially Equivalent on 1998-04-01. Applicant: Reddy Medtech Health Products , Ltd.. Device class: 2.

Clearance details

Applicant: Reddy Medtech Health Products , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1998-01-02
Decision date: 1998-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chennai, IN

Download summary PDF View on FDA.gov ↗

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