Nuance FLOW— 510(k) K143679

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K143679 for Nuance FLOW, Substantially Equivalent on 2015-05-01. Applicant: Den-Mat Holdings, LLC. Device class: 2.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2014-12-24
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lompoc, CA, 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.