Device Classification Name |
drill, bone, powered
|
510(k) Number |
K091252 |
Device Name |
IMPLANT CENTER 2 |
Applicant |
SATELEC |
124 GAITHER DRIVE |
SUITE 140 |
MT. LAUREL,
NJ
08054
|
|
Applicant Contact |
RICK ROSATI |
Correspondent |
SATELEC |
124 GAITHER DRIVE |
SUITE 140 |
MT. LAUREL,
NJ
08054
|
|
Correspondent Contact |
RICK ROSATI |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 04/29/2009 |
Decision Date | 07/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|