PIEZO BONE SURGERY


Device Classification Name

drill, bone, powered

510(k) Number K111290
Device Name PIEZO BONE SURGERY
Applicant
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
7325 joyce way
echo, 
OR 
97826

Applicant Contact charlie mack
Correspondent
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
7325 joyce way
echo, 
OR 
97826

Correspodent Contact charlie mack
Regulation Number 872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received 05/06/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No