Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K120686 |
Device Name |
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
Applicant |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
KIM FONDA |
Correspondent |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
KIM FONDA |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/06/2012 |
Decision Date | 04/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|