Device Classification Name |
Enema Kit
|
510(k) Number |
K842130 |
Device Name |
G.I. CLEANSING KIT |
Applicant |
MMI, INC. |
19500 WEST EIGHT MILE RD. |
P.O. BOX 305 |
SOUTHFIELD,
MI
48037
|
|
Applicant Contact |
MARTIN MATTLER |
Correspondent |
MMI, INC. |
19500 WEST EIGHT MILE RD. |
P.O. BOX 305 |
SOUTHFIELD,
MI
48037
|
|
Correspondent Contact |
MARTIN MATTLER |
Regulation Number | 876.5210
|
Classification Product Code |
|
Date Received | 05/30/1984 |
Decision Date | 08/08/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|