PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE— 510(k) K080220

Name: FDA 510(k) clearance K080220
Creator: U.S. Food and Drug Administration
Published: 2008-07-28

Substantially Equivalent

Italia Medica S.R.L.

FDA 510(k) clearance K080220 for PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE, Substantially Equivalent on 2008-07-28. Applicant: Italia Medica S.R.L.. Device class: 2.

Clearance details

Applicant: Italia Medica S.R.L.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2008-01-29
Decision date: 2008-07-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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