TCM ENDO III— 510(k) K013185

Substantially Equivalent

NOUVAG AG

FDA 510(k) clearance K013185 for TCM ENDO III, Substantially Equivalent on 2001-11-28. Applicant: NOUVAG AG. Device class: 1.

Clearance details

Applicant: NOUVAG AG
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2001-09-24
Decision date: 2001-11-28
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.