SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM— 510(k) K943933

Name: FDA 510(k) clearance K943933
Creator: U.S. Food and Drug Administration
Published: 1995-06-22

Substantially Equivalent

Aladan Corp.

FDA 510(k) clearance K943933 for SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM, Substantially Equivalent on 1995-06-22. Applicant: Aladan Corp.. Device class: 2.

Clearance details

Applicant: Aladan Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1994-08-12
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

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