Device Classification Name |
mesh, surgical
|
510(k) Number |
K142070 |
Device Name |
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS |
Applicant |
RTI SURGICAL, INC. |
11621 Research Cir |
ALACHUA,
FL
32615
|
|
Applicant Contact |
KRISTINA HALL |
Correspondent |
RTI SURGICAL, INC. |
11621 Research Cir |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
KRISTINA HALL |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/30/2014 |
Decision Date | 10/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|