Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K152868 |
Device Name |
ExpressBraid Graft Manipulation |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE PO BOX 587 |
WARSAW,
IL
46581
|
|
Applicant Contact |
ADAM CARGILL |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE PO BOX 587 |
WARSAW,
IL
46581
|
|
Correspondent Contact |
ADAM CARGILL |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 09/30/2015 |
Decision Date | 02/08/2016 |
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
|