Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K163576 |
Device Name |
GORE SYNECOR Preperitoneal Biomaterial |
Applicant |
W. L. Gore & Associates, Inc. |
1505 N. Fourth Street |
Flagstaff,
AZ
86004
|
|
Applicant Contact |
Michael J. Titus |
Correspondent |
W. L. Gore & Associates, Inc. |
1505 N. Fourth Street |
Flagstaff,
AZ
86004
|
|
Correspondent Contact |
Michael J. Titus |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/19/2016 |
Decision Date | 05/11/2017 |
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
|