TEMPOFIT, MODEL 02693— 510(k) K994012

Substantially Equivalent

Detax GmbH & Co. KG

FDA 510(k) clearance K994012 for TEMPOFIT, MODEL 02693, Substantially Equivalent on 2000-02-16. Applicant: Detax GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Detax GmbH & Co. KG
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1999-11-26
Decision date: 2000-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belton, MO, 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.