Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K192636 |
Device Name |
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) |
Applicant |
Medtronic, Inc. |
8200 Coral Sea St NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
Nancy Cameron |
Correspondent |
Medtronic, Inc. |
8200 Coral Sea St NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Nancy Cameron |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/23/2019 |
Decision Date | 04/08/2020 |
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
|