Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K071887 |
Device Name |
SPORTMESH OR ARTELON TISSUE REINFORCEMENT |
Applicant |
ARTIMPLANT AB |
719 A STREET NE |
WASHINGTON,
DC
20002
|
|
Applicant Contact |
TERRY S POWELL |
Correspondent |
ARTIMPLANT AB |
719 A STREET NE |
WASHINGTON,
DC
20002
|
|
Correspondent Contact |
TERRY S POWELL |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/09/2007 |
Decision Date | 09/18/2007 |
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
|