OPHIRA MINI SLING SYSTEM


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

510(k) Number K110420
Device Name OPHIRA MINI SLING SYSTEM
Applicant
PROMEDON S.A.
221 ellis parkway
piscataway, 
NJ 
08854

Applicant Contact stephanie rais
Correspondent
PROMEDON S.A.
221 ellis parkway
piscataway, 
NJ 
08854

Correspodent Contact stephanie rais
Regulation Number 878.3300
Classification Product Code
PAH  
Date Received 02/14/2011
Decision Date 05/08/2012
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