Device Classification Name |
Mesh, Surgical, Absorbable, Abdominal Hernia
|
510(k) Number |
K101287 |
Device Name |
TEPHAFLEX COMPOSITE MESH |
Applicant |
TEPHA, INC. |
99 HAYDEN AVENUE, |
SUITE 360 |
LEXINGTON,
MA
02421
|
|
Applicant Contact |
MARY P LEGRAW |
Correspondent |
TEPHA, INC. |
99 HAYDEN AVENUE, |
SUITE 360 |
LEXINGTON,
MA
02421
|
|
Correspondent Contact |
MARY P LEGRAW |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/07/2010 |
Decision Date | 08/30/2010 |
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
|
|
|