Device Classification Name |
applier, aneurysm clip
|
510(k) Number |
K940970 |
Device Name |
YASARGIL, CASPAR, VARIO CLIP APPLIERS |
Applicant |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
VISTORIA MACKINNON |
Correspondent |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
VISTORIA MACKINNON |
Regulation Number | 882.4175
|
Classification Product Code |
|
Date Received | 03/02/1994 |
Decision Date | 01/24/1995 |
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
|
|
|