TCM ENDO 20


Device Classification Name

handpiece, direct drive, ac-powered

510(k) Number K081191
Device Name TCM ENDO 20
Applicant
NOUVAG AG
reusswehrstrasse 1
gebenstorf, 

CH

ch-5412

Applicant Contact erich forster
Correspondent
NOUVAG AG
reusswehrstrasse 1
gebenstorf, 

CH

ch-5412

Correspodent Contact erich forster
Regulation Number 872.4200
Classification Product Code
EKX  
Date Received 04/28/2008
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No