CALEX CONDITIONER— 510(k) K010176

Substantially Equivalent

Stephen M Koral, Dmd

FDA 510(k) clearance K010176 for CALEX CONDITIONER, Substantially Equivalent on 2001-03-27. Applicant: Stephen M Koral, Dmd. Device class: 2.

Clearance details

Applicant: Stephen M Koral, Dmd
Product code: Code EJK
Device class: Class 2
Regulation: 21 CFR 872.3250
Advisory panel: Dental
Date received: 2001-01-18
Decision date: 2001-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Stephen M Koral, Dmd

K013993 — NEOCALEX2002-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.