Device Classification Name |
clip, implantable
|
510(k) Number |
K062821 |
Device Name |
U-CLIP DEVICE |
Applicant |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR. |
GOLETA,
CA
93117
|
|
Applicant Contact |
JEFFREY HENDERSON |
Correspondent |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
JEFFREY HENDERSON |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 09/20/2006 |
Decision Date | 12/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|