ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS— 510(k) K971132

Name: FDA 510(k) clearance K971132
Creator: U.S. Food and Drug Administration
Published: 1997-09-03

Substantially Equivalent

G. Premjee (Usa), Inc.

FDA 510(k) clearance K971132 for ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS, Substantially Equivalent on 1997-09-03. Applicant: G. Premjee (Usa), Inc.. Device class: 2.

Clearance details

Applicant: G. Premjee (Usa), Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-27
Decision date: 1997-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.