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
|
|
Correspondent Contact |
ERICH FORSTER |
Regulation Number | 872.4200
|
Classification Product Code |
|
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
|
|
|