Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K020298 |
Device Name |
GALILEO CAS/NAV TKR SYSTEM |
Applicant |
PLUS ORTHOPEDICS |
6055 LUSK BLVD. |
SAN DIEGO,
CA
92121 -2700
|
|
Applicant Contact |
HARTMUT LOCH |
Correspondent |
PLUS ORTHOPEDICS |
6055 LUSK BLVD. |
SAN DIEGO,
CA
92121 -2700
|
|
Correspondent Contact |
HARTMUT LOCH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 01/28/2002 |
Decision Date | 05/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|