Device Classification Name |
Enema Kit
|
510(k) Number |
K833860 |
Device Name |
TUCK-TITE COLON FLUID RETAINER |
Applicant |
CLAYTON MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CLAYTON MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5210
|
Classification Product Code |
|
Date Received | 11/07/1983 |
Decision Date | 12/27/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|