Device Classification Name |
Surgical Film
|
510(k) Number |
K070894 |
Device Name |
TEPHAFLEX SURGICAL MESH |
Applicant |
TEPHA, INC. |
840 MEMORIAL DRIVE |
3RD FLOOR |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
MARY P LEGRAW |
Correspondent |
TEPHA, INC. |
840 MEMORIAL DRIVE |
3RD FLOOR |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
MARY P LEGRAW |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2007 |
Decision Date | 04/13/2007 |
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
|
|
|