Device Classification Name |
rod, colostomy
|
510(k) Number |
K052229 |
Device Name |
COLOPLAST OSTOMY ROD, MODEL 12814 |
Applicant |
COLOPLAST CORP. |
1940 COMMERCE DR. |
NORTH MANKATO,
MN
56003
|
|
Applicant Contact |
ELIZABETH BOOTS |
Correspondent |
COLOPLAST CORP. |
1940 COMMERCE DR. |
NORTH MANKATO,
MN
56003
|
|
Correspondent Contact |
ELIZABETH BOOTS |
Regulation Number | 876.4270
|
Classification Product Code |
|
Date Received | 08/16/2005 |
Decision Date | 10/13/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|