Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K162570 |
Device Name |
Miromatrix Biological Mesh TW |
Applicant |
Miromatrix Medical Inc. |
18683 Bearpath Trail |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Jeff Ross |
Correspondent |
Biologics Consulting Group, Inc. |
400 N. Washington St., Suite 100 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Miriam C. Provost |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/15/2016 |
Decision Date | 02/16/2017 |
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
|
|
|