OSTOMY IRRIGATION SET


Device Classification Name

irrigator, ostomy

510(k) Number K121833
Device Name OSTOMY IRRIGATION SET
Applicant
COLOPLAST A/S
1601 west river road n
minneapolis, 
MN 
55411

Applicant Contact tim crabtree
Correspondent
COLOPLAST A/S
1601 west river road n
minneapolis, 
MN 
55411

Correspodent Contact tim crabtree
Regulation Number 876.5895
Classification Product Code
EXD  
Date Received 06/22/2012
Decision Date 07/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No