Device Classification Name |
mesh, surgical, collagen, plastic and reconstructive surgery
|
510(k) Number |
K160400 |
Device Name |
Miromatrix Biological Mesh |
Applicant |
MIROMATRIX MEDICAL INC. |
10399 WEST 70TH ST |
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 | 02/12/2016 |
Decision Date | 06/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|