Device Classification Name |
Enema Kit
|
510(k) Number |
K900847 |
Device Name |
ENEMA KIT 'Y' DESIGN |
Applicant |
CUSTOM MEDICAL PRODUCTS, LTD. |
4101 SPRING MILL WAY |
MAINEVILLE,
OH
45039
|
|
Applicant Contact |
GEORGE C SCHULER |
Correspondent |
CUSTOM MEDICAL PRODUCTS, LTD. |
4101 SPRING MILL WAY |
MAINEVILLE,
OH
45039
|
|
Correspondent Contact |
GEORGE C SCHULER |
Regulation Number | 876.5210
|
Classification Product Code |
|
Date Received | 02/22/1990 |
Decision Date | 04/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|