Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K123356 |
Device Name |
FORTIVA PORCINE DERMIS |
Applicant |
RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE |
P.O. BOX 2650 |
ALACHUA,
FL
32616 -1627
|
|
Applicant Contact |
ESTHER CARBON |
Correspondent |
RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE |
P.O. BOX 2650 |
ALACHUA,
FL
32616 -1627
|
|
Correspondent Contact |
ESTHER CARBON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/31/2012 |
Decision Date | 03/05/2013 |
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
|
|
|