E-STATIS 40 SYSTEM— 510(k) K090937

Substantially Equivalent

Scican , Ltd.

FDA 510(k) clearance K090937 for E-STATIS 40 SYSTEM, Substantially Equivalent on 2009-07-24. Applicant: Scican , Ltd.. Device class: 1.

Clearance details

Applicant: Scican , Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-04-03
Decision date: 2009-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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