LUBRICANO-ULTRASOUND— 510(k) K083358

Substantially Equivalent

Farco Pharma GmbH

FDA 510(k) clearance K083358 for LUBRICANO-ULTRASOUND, Substantially Equivalent on 2009-01-09. Applicant: Farco Pharma GmbH. Device class: 2.

Clearance details

Applicant: Farco Pharma GmbH
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2008-10-14
Decision date: 2009-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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