Device Classification Name |
mesh, surgical
|
510(k) Number |
K081882 |
Device Name |
MODIFICATION TO XYLOS SURGICAL MESH |
Applicant |
XYLOS CORPORATION |
838 TOWN CENTER DR. |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
GERRY ANN OSTER |
Correspondent |
XYLOS CORPORATION |
838 TOWN CENTER DR. |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
GERRY ANN OSTER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/02/2008 |
Decision Date | 07/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|