Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K163651 |
Device Name |
ExpressBraid Graft Manipulation |
Applicant |
Biomet Manufacturing Corp. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Applicant Contact |
Vinay Bhal |
Correspondent |
Biomet Manufacturing Corp. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Vinay Bhal |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 12/23/2016 |
Decision Date | 02/17/2017 |
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
|