Device Classification Name |
surgical film
|
510(k) Number |
K113723 |
Device Name |
TEPHAFLEX MESH |
Applicant |
TEPHA, INC. |
99 HAYDEN, SUITE 360 |
LEXINGTON,
MA
02421
|
|
Applicant Contact |
MARY P LEGRAW |
Correspondent |
TEPHA, INC. |
99 HAYDEN, SUITE 360 |
LEXINGTON,
MA
02421
|
|
Correspondent Contact |
MARY P LEGRAW |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/19/2011 |
Decision Date | 02/15/2012 |
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
|
|
|