Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K012456 |
Device Name |
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) |
Applicant |
SODEM SYSTEMS |
110 CH. DU PONT DU CENTENAIRE |
GENEVA,
CH
CH-1228
|
|
Applicant Contact |
CAROLE BURNIER |
Correspondent |
SODEM SYSTEMS |
110 CH. DU PONT DU CENTENAIRE |
GENEVA,
CH
CH-1228
|
|
Correspondent Contact |
CAROLE BURNIER |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 08/01/2001 |
Decision Date | 09/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|