Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K170763 |
Device Name |
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend |
Applicant |
ACell, Inc. |
6640 Eli Whitney Drive |
Columbia,
MD
21046
|
|
Applicant Contact |
Salman Elmi |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street, NW |
Washington DC,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/13/2017 |
Decision Date | 06/08/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|