ENADEN FLOW— 510(k) K140976

Substantially Equivalent

Km Corporation

FDA 510(k) clearance K140976 for ENADEN FLOW, Substantially Equivalent on 2014-07-10. Applicant: Km Corporation. Device class: 2.

Clearance details

Applicant: Km Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2014-04-16
Decision date: 2014-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, 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.