Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K053542 |
Device Name |
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM |
Applicant |
PRAXIM SA |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
RANDY VEALE |
Correspondent |
PRAXIM SA |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
RANDY VEALE |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/20/2005 |
Decision Date | 04/10/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|