Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
|
510(k) Number |
K023898 |
Device Name |
GYNE IDEAS MINITAPE RP DEVICE |
Applicant |
GYNE IDEAS LTD. |
150 ARAN HILL RD. |
FAIRFIELD,
CT
06824
|
|
Applicant Contact |
LOUIS MAZZARESE |
Correspondent |
GYNE IDEAS LTD. |
150 ARAN HILL RD. |
FAIRFIELD,
CT
06824
|
|
Correspondent Contact |
LOUIS MAZZARESE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/22/2002 |
Decision Date | 06/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|