SURGISIS SLING


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

Correspodent Contact neal e fearnot
Regulation Number 878.3300
Classification Product Code
PAG  
Subsequent Product Codes
FTM   PAJ  
Date Received 06/25/1999
Decision Date 09/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No