RESCUE EXTERNAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K081302
Device Name RESCUE EXTERNAL IMPLANT SYSTEM
Applicant
MEGAGEN IMPLANT CO., LTD
13340 e. firestone blvd.
suite j
santa fe springs, 
CA 
90670

Applicant Contact jung b bang
Correspondent
MEGAGEN IMPLANT CO., LTD
13340 e. firestone blvd.
suite j
santa fe springs, 
CA 
90670

Correspodent Contact jung b bang
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 05/08/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No