ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS— 510(k) K972836

Name: FDA 510(k) clearance K972836
Creator: U.S. Food and Drug Administration
Published: 1997-10-22

Substantially Equivalent

G. Premjee (Usa), Inc.

FDA 510(k) clearance K972836 for ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS, Substantially Equivalent on 1997-10-22. Applicant: G. Premjee (Usa), Inc.. Device class: 2.

Clearance details

Applicant: G. Premjee (Usa), Inc.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1997-07-31
Decision date: 1997-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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