Device Classification Name |
Suture, Recombinant Technology
|
510(k) Number |
K122487 |
Device Name |
BIOFIBER SYTURE |
Applicant |
TORNIER, INC. |
10801 NESBITT AVENUE |
BLOOMINGTON,
MN
55437
|
|
Applicant Contact |
LAEL J PICKETT |
Correspondent |
TORNIER, INC. |
10801 NESBITT AVENUE |
BLOOMINGTON,
MN
55437
|
|
Correspondent Contact |
LAEL J PICKETT |
Regulation Number | 878.4494
|
Classification Product Code |
|
Date Received | 08/15/2012 |
Decision Date | 09/17/2012 |
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
|
|
|