Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K943468 |
Device Name |
LEKSELL SURGIPLAN |
Applicant |
ELEKTA INSTRUMENTS, INC. |
8 EXECUTIVE PARK WEST |
ATLANTA,
GA
30329
|
|
Applicant Contact |
TOM PARKER |
Correspondent |
ELEKTA INSTRUMENTS, INC. |
8 EXECUTIVE PARK WEST |
ATLANTA,
GA
30329
|
|
Correspondent Contact |
TOM PARKER |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/19/1994 |
Decision Date | 01/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|