Sonablate 450— 510(k) DEN150011

Unknown

Sonacare Medical, LLC

FDA 510(k) clearance DEN150011 for Sonablate 450, Unknown on 2015-10-09. Applicant: Sonacare Medical, LLC. Device class: 2.

Clearance details

Applicant: Sonacare Medical, LLC
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-23
Decision date: 2015-10-09
Decision: Unknown
Clearance type: Direct
Location: Charlotte, NC, US

View on FDA.gov ↗

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