Device Classification Name |
clip, implantable
|
510(k) Number |
K111930 |
Device Name |
ACKERMANN EUROPCLIP |
Applicant |
ACKERMANN INSTRUMENTE GMBH |
8202 SHERMAN ROAD |
CHESTERLAND,
OH
44026 -2141
|
|
Applicant Contact |
KAREN E WARDEN, PHD |
Correspondent |
ACKERMANN INSTRUMENTE GMBH |
8202 SHERMAN ROAD |
CHESTERLAND,
OH
44026 -2141
|
|
Correspondent Contact |
KAREN E WARDEN, PHD |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/07/2011 |
Decision Date | 11/08/2011 |
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
|
|
|