Device Classification Name |
Handpiece, Contra- And Right-Angle Attachment, Dental
|
510(k) Number |
K011061 |
Device Name |
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 |
Applicant |
W & H DENTALWERK BUERMOOS GMBH |
53 IGNAZ-GLAZER-STRASSE |
BUERMOOS,
AT
5111
|
|
Applicant Contact |
HERBERT TRASCHWANDTNER |
Correspondent |
W & H DENTALWERK BUERMOOS GMBH |
53 IGNAZ-GLAZER-STRASSE |
BUERMOOS,
AT
5111
|
|
Correspondent Contact |
HERBERT TRASCHWANDTNER |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 04/06/2001 |
Decision Date | 06/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|