URETRON MODEL URT— 510(k) K111058

Substantially Equivalent

Med-Sonics Corp.

FDA 510(k) clearance K111058 for URETRON MODEL URT, Substantially Equivalent on 2012-03-30. Applicant: Med-Sonics Corp.. Device class: 2.

Clearance details

Applicant: Med-Sonics Corp.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2011-04-18
Decision date: 2012-03-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

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