NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL— 510(k) K002060

Name: FDA 510(k) clearance K002060
Creator: U.S. Food and Drug Administration
Published: 2000-09-07

Substantially Equivalent

Dongkuk Techco Rubber Industries

FDA 510(k) clearance K002060 for NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL, Substantially Equivalent on 2000-09-07. Applicant: Dongkuk Techco Rubber Industries. Device class: 2.

Clearance details

Applicant: Dongkuk Techco Rubber Industries
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2000-07-06
Decision date: 2000-09-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Penang, MY

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.