SPERMICIDAL CONDOM— 510(k) K874464

Name: FDA 510(k) clearance K874464
Creator: U.S. Food and Drug Administration
Published: 1987-11-20

Substantially Equivalent

Royal American Industries, Inc.

FDA 510(k) clearance K874464 for SPERMICIDAL CONDOM, Substantially Equivalent on 1987-11-20. Applicant: Royal American Industries, Inc.. Device class: 2.

Clearance details

Applicant: Royal American Industries, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-10-26
Decision date: 1987-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.