JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS— 510(k) K854247

Name: FDA 510(k) clearance K854247
Creator: U.S. Food and Drug Administration
Published: 1986-01-16

Substantially Equivalent

M/S Seohung Industrial Co., Ltd.

FDA 510(k) clearance K854247 for JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS, Substantially Equivalent on 1986-01-16. Applicant: M/S Seohung Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: M/S Seohung Industrial Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1985-10-21
Decision date: 1986-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cameron, TX, 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.