Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K061224 |
Device Name |
LAPDOC I |
Applicant |
ROBODENT GMBH |
KURFURSTENDAMM 213 |
BERLIN,
DE
10719
|
|
Applicant Contact |
JUERGEN BIER |
Correspondent |
ROBODENT GMBH |
KURFURSTENDAMM 213 |
BERLIN,
DE
10719
|
|
Correspondent Contact |
JUERGEN BIER |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 05/01/2006 |
Decision Date | 09/05/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|