ISODAN— 510(k) K010415

Substantially Equivalent

Specialites Septodont

FDA 510(k) clearance K010415 for ISODAN, Substantially Equivalent on 2001-07-23. Applicant: Specialites Septodont. Device class: 2.

Clearance details

Applicant: Specialites Septodont
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2001-02-12
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Specialites Septodont

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K920692 — SEPTOCALCINE ULTRA1992-04-21

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