Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K191268 |
Device Name |
Force Fiber Suture |
Applicant |
Teleflex Medical Incorporated |
375 Forbes Boulevard |
Mansfield,
MA
02048
|
|
Applicant Contact |
Andrea Curria |
Correspondent |
Teleflex Medical Incorporated |
375 Forbes Boulevard |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Andrea Curria |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 06/11/2019 |
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
|
|
|