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
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 876.5895
|
Classification Product Code |
|
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
|
|
|