LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT— 510(k) K974323

Name: FDA 510(k) clearance K974323
Creator: U.S. Food and Drug Administration
Published: 1998-02-10

Substantially Equivalent

Reddy Medtech Health Products , Ltd.

FDA 510(k) clearance K974323 for LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT, Substantially Equivalent on 1998-02-10. 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: 1997-11-18
Decision date: 1998-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainsboro, NJ, US

Download summary PDF View on FDA.gov ↗

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K980019 — HTL MALE CONDOM1998-04-01
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K974326 — LATEX CONDOMS (NATURAL COLOUR)1998-02-09

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