PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed

510(k) Number K072951
Device Name PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Applicant
SOFRADIM PRODUCTION
150 glover avenue
norwalk, 
CT 
06856

Applicant Contact sharon alexander
Correspondent
SOFRADIM PRODUCTION
150 glover avenue
norwalk, 
CT 
06856

Correspodent Contact sharon alexander
Regulation Number 878.3300
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received 10/18/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No