| Device Classification Name |
mesh, surgical, polymeric
|
|---|
| 510(k) Number |
K974540 |
|---|
| Device Name |
SIS HERNIA REPAIR DEVICE |
|---|
| Applicant |
| SENTRON MEDICAL, INC. |
| 4445 LAKE FOREST DR. |
| SUITE 600 |
|
CINCINNATI,
OH
45242
|
|
| Applicant Contact |
ROBERT J MORFF |
| Correspondent |
| SENTRON MEDICAL, INC. |
| 4445 LAKE FOREST DR. |
| SUITE 600 |
|
CINCINNATI,
OH
45242
|
|
| Correspondent Contact |
ROBERT J MORFF |
| Regulation Number | 878.3300
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/03/1997 |
|---|
| Decision Date | 05/20/1998 |
|---|
| 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
|
|---|