SMILIE PC— 510(k) K001445

Substantially Equivalent

Julie Alliance

FDA 510(k) clearance K001445 for SMILIE PC, Substantially Equivalent on 2000-07-26. Applicant: Julie Alliance. Device class: 1.

Clearance details

Applicant: Julie Alliance
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2000-05-08
Decision date: 2000-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, 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.