PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE


Device Classification Name

drill, bone, powered

510(k) Number K080220
Device Name PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
Applicant
ITALIA MEDICA S.R.L.
110 e. granada blvd. suite 207
ormond beach, 
FL 
32176

Applicant Contact berthoin claude
Correspondent
ITALIA MEDICA S.R.L.
110 e. granada blvd. suite 207
ormond beach, 
FL 
32176

Correspodent Contact berthoin claude
Regulation Number 872.4120
Classification Product Code
DZI  
Date Received 01/29/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No