Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K081538 |
Device Name |
TUTOPATCH, TUTOMESH |
Applicant |
RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE |
P.O. BOX 2650 |
ALACHUA,
FL
32616 -1627
|
|
Applicant Contact |
TRAVIS AROLA |
Correspondent |
RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE |
P.O. BOX 2650 |
ALACHUA,
FL
32616 -1627
|
|
Correspondent Contact |
TRAVIS AROLA |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/02/2008 |
Decision Date | 06/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|