ULTRASONIC SURGICAL UNIT


Device Classification Name

drill, bone, powered

510(k) Number K110881
Device Name ULTRASONIC SURGICAL UNIT
Applicant
DONG IL TECHNOLOGY LTD.
300 atwood
pittsburgh, 
PA 
15213

Applicant Contact peter chung
Correspondent
DONG IL TECHNOLOGY LTD.
300 atwood
pittsburgh, 
PA 
15213

Correspodent Contact peter chung
Regulation Number 872.4120
Classification Product Code
DZI  
Date Received 03/30/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No