Device Classification Name |
Clip, Aneurysm
|
510(k) Number |
K024349 |
Device Name |
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
MATTHEW M HULL |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
MATTHEW M HULL |
Regulation Number | 882.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/30/2002 |
Decision Date | 03/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|