Device Classification Name |
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
|
510(k) Number |
K121216 |
Device Name |
STR GRAFT |
Applicant |
SOFT TISSUE REGENERATION, INC. |
815 IRIS LANE |
VERO BEACH,
FL
32963
|
|
Applicant Contact |
ROBERT A POGGIE |
Correspondent |
SOFT TISSUE REGENERATION, INC. |
815 IRIS LANE |
VERO BEACH,
FL
32963
|
|
Correspondent Contact |
ROBERT A POGGIE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/23/2012 |
Decision Date | 11/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|