Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K130943 |
Device Name |
AIGIS RX R PM/ AIGIS RX R ICD |
Applicant |
TYRX , INC. |
1 DEER PARK DR. |
SUITE G |
MONMOUTH JUNCTION,
NJ
08852
|
|
Applicant Contact |
SUSAN OLINGER |
Correspondent |
TYRX , INC. |
1 DEER PARK DR. |
SUITE G |
MONMOUTH JUNCTION,
NJ
08852
|
|
Correspondent Contact |
SUSAN OLINGER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/04/2013 |
Decision Date | 05/20/2013 |
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 |
Yes
|