EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM


Device Classification Name

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

510(k) Number K112386
Device Name EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant
COLOPLAST CORP.
1601 west river n
minneapolis, 
MN 
55411

Applicant Contact tim crabtree
Correspondent
COLOPLAST CORP.
1601 west river n
minneapolis, 
MN 
55411

Correspodent Contact tim crabtree
Regulation Number 878.3300
Classification Product Code
OTP  
Date Received 08/18/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No