OKAMOTO ULTRA THIN— 510(k) K090259

Substantially Equivalent

Okamoto USA, Inc.

FDA 510(k) clearance K090259 for OKAMOTO ULTRA THIN, Substantially Equivalent on 2009-03-31. 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: 2009-02-02
Decision date: 2009-03-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, 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.