Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K181774 |
Device Name |
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 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 |
|
Subsequent Product Codes |
|
Date Received | 07/03/2018 |
Decision Date | 10/10/2018 |
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
|