EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER— 510(k) K041416

Name: FDA 510(k) clearance K041416
Creator: U.S. Food and Drug Administration
Published: 2004-07-02

Substantially Equivalent

Deroyal

FDA 510(k) clearance K041416 for EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER, Substantially Equivalent on 2004-07-02. Applicant: Deroyal. Device class: 2.

Clearance details

Applicant: Deroyal
Product code: Code EYC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-05-27
Decision date: 2004-07-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

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