D-CARIE, MODEL N121-M1— 510(k) K043156

Substantially Equivalent

Neks Technologies, Inc.

FDA 510(k) clearance K043156 for D-CARIE, MODEL N121-M1, Substantially Equivalent on 2005-04-28. Applicant: Neks Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Neks Technologies, Inc.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2004-11-15
Decision date: 2005-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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