Device Classification Name |
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K992159 |
Device Name |
SURGISIS SLING |
Applicant |
COOK BIOTECH, INC. |
3055 KENT AVE. |
WEST LAFAYETTE,
IN
47906 -1076
|
|
Applicant Contact |
NEAL E FEARNOT |
Correspondent |
COOK BIOTECH, INC. |
3055 KENT AVE. |
WEST LAFAYETTE,
IN
47906 -1076
|
|
Correspondent Contact |
NEAL E FEARNOT |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/25/1999 |
Decision Date | 09/23/1999 |
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
|
|
|