ELEMENTS DIAGNOSTIC UNIT— 510(k) K021298

Substantially Equivalent

Sybron Endo/Analytic

FDA 510(k) clearance K021298 for ELEMENTS DIAGNOSTIC UNIT, Substantially Equivalent on 2002-06-19. Applicant: Sybron Endo/Analytic. Device class: 2.

Clearance details

Applicant: Sybron Endo/Analytic
Product code: Code EAT
Device class: Class 2
Regulation: 21 CFR 872.1720
Advisory panel: Dental
Date received: 2002-04-24
Decision date: 2002-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, 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.