Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K090880 |
Device Name |
XYLOS POROUS SURGICAL MESH |
Applicant |
XYLOS CORPORATION |
838 TOWN CENTER DR. |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
JOYCE ELKINS |
Correspondent |
XYLOS CORPORATION |
838 TOWN CENTER DR. |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
JOYCE ELKINS |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/31/2009 |
Decision Date | 05/27/2009 |
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
|