Device Classification Name |
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
|
510(k) Number |
K051190 |
Device Name |
XENFORM SOFT TISSUE REPAIR MATRIX |
Applicant |
TEI BIOSCIENCES INC. |
7 ELKINS ST. |
BOSTON,
MA
02127
|
|
Applicant Contact |
KENNETH JAMES |
Correspondent |
TEI BIOSCIENCES INC. |
7 ELKINS ST. |
BOSTON,
MA
02127
|
|
Correspondent Contact |
KENNETH JAMES |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/10/2005 |
Decision Date | 06/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|