Device Classification Name |
mesh, surgical, absorbable, abdominal hernia
|
510(k) Number |
K191749 |
Device Name |
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |
Applicant |
Novus Scientific AB |
Virdings Alle 2 |
Uppsala,
SE
se-754 50
|
|
Applicant Contact |
Thomas Engstrom |
Correspondent |
Cygnus Regulatory, LLC |
5555 E Palo Verde Drive |
Paradise Valley,
AZ
85253
|
|
Correspondent Contact |
Loredana M Guseila |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/01/2019 |
Decision Date | 03/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01622725
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|