Device Classification Name |
Enema Kit
|
510(k) Number |
K832960 |
Device Name |
SHUFFIELD TECH ENEMA TIP |
Applicant |
SHUFFIELD TECH CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SHUFFIELD TECH CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5210
|
Classification Product Code |
|
Date Received | 08/30/1983 |
Decision Date | 01/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|