Device Classification Name |
Clip, Aneurysm
|
510(k) Number |
K081640 |
Device Name |
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS |
Applicant |
GIMMI GMBH |
ONE SCANLAN PLAZA |
SAINT PAUL,
MN
55107
|
|
Applicant Contact |
KEN BLAKE |
Correspondent |
GIMMI GMBH |
ONE SCANLAN PLAZA |
SAINT PAUL,
MN
55107
|
|
Correspondent Contact |
KEN BLAKE |
Regulation Number | 882.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2008 |
Decision Date | 05/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|