Device Classification Name |
surgical film
|
510(k) Number |
K091633 |
FOIA Releasable 510(k) |
K091633
|
Device Name |
TEPHAFLEX SURGICAL FILM |
Applicant |
TEPHA, INC. |
99 HAYDEN, SUTIE 360 |
LEXINGTON,
MA
02421
|
|
Applicant Contact |
MARY P LEGRAW |
Correspondent |
TEPHA, INC. |
99 HAYDEN, SUTIE 360 |
LEXINGTON,
MA
02421
|
|
Correspondent Contact |
MARY P LEGRAW |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2009 |
Decision Date | 08/07/2009 |
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
|
|
|