| Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
|
|---|
| 510(k) Number |
K053361 |
|---|
| Device Name |
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH |
|---|
| Applicant |
| MPATHY MEDICAL DEVICES, LTD. |
| 150 ARAN HILL ROAD |
|
FAIRFIELD,
CT
06824 -1712
|
|
| Applicant Contact |
LOUIS J MAZZARESE |
| Correspondent |
| MPATHY MEDICAL DEVICES, LTD. |
| 150 ARAN HILL ROAD |
|
FAIRFIELD,
CT
06824 -1712
|
|
| Correspondent Contact |
LOUIS J MAZZARESE |
| Regulation Number | 878.3300
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 12/02/2005 |
|---|
| Decision Date | 02/06/2006 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
Obstetrics/Gynecology
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|