DYNAREX ULTRASOUND GEL— 510(k) K102637

Substantially Equivalent

Dynarex Corporation

FDA 510(k) clearance K102637 for DYNAREX ULTRASOUND GEL, Substantially Equivalent on 2011-02-16. Applicant: Dynarex Corporation. Device class: 2.

Clearance details

Applicant: Dynarex Corporation
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2010-09-14
Decision date: 2011-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, 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.