RUBBER CONTRACEPTIVE, LATEX CONDOMS— 510(k) K875111

Name: FDA 510(k) clearance K875111
Creator: U.S. Food and Drug Administration
Published: 1988-02-26

Substantially Equivalent

Okamoto USA, Inc.

FDA 510(k) clearance K875111 for RUBBER CONTRACEPTIVE, LATEX CONDOMS, Substantially Equivalent on 1988-02-26. Applicant: Okamoto USA, Inc.. Device class: 2.

Clearance details

Applicant: Okamoto USA, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-12-14
Decision date: 1988-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stratford, CT, 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.