Device Classification Name |
Clip, Aneurysm
|
510(k) Number |
K091921 |
Device Name |
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP |
Applicant |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
PAUL AMARAL |
Correspondent |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
PAUL AMARAL |
Regulation Number | 882.5200
|
Classification Product Code |
|
Date Received | 06/30/2009 |
Decision Date | 09/08/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|