Device Classification Name |
clip, aneurysm
|
510(k) Number |
K955064 |
Device Name |
SPETZLER TI 100 ANEURYSM CLIP |
Applicant |
ELEKTA INSTRUMENTS, INC. |
8 EXECUTIVE PARK WEST |
ATLANTA,
GA
30329
|
|
Applicant Contact |
MICHAEL LANG |
Correspondent |
ELEKTA INSTRUMENTS, INC. |
8 EXECUTIVE PARK WEST |
ATLANTA,
GA
30329
|
|
Correspondent Contact |
MICHAEL LANG |
Regulation Number | 882.5200
|
Classification Product Code |
|
Date Received | 11/06/1995 |
Decision Date | 10/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|