Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K142192 |
Device Name |
Insightra Freedom Ventral Hernia Repair System |
Applicant |
Insightra Medical |
9200 Irvine Center Drive |
Suite 200 |
Irvine,
CA
92618
|
|
Applicant Contact |
Neerav Parikh |
Correspondent |
Insightra Medical |
9200 Irvine Center Drive |
Suite 200 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Neerav Parikh |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/11/2014 |
Decision Date | 05/07/2015 |
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
|