Device Classification Name |
enema kit
|
510(k) Number |
K901182 |
Device Name |
ENEMA BAG SET |
Applicant |
ORION LIFE SYSTEMS, INC. |
124 MESSNER DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
JOHN L LAEMMAR |
Correspondent |
ORION LIFE SYSTEMS, INC. |
124 MESSNER DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
JOHN L LAEMMAR |
Regulation Number | 876.5210
|
Classification Product Code |
|
Date Received | 03/13/1990 |
Decision Date | 06/28/1990 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|