Device Classification Name |
collector, ostomy
|
510(k) Number |
K873929 |
Device Name |
'CATCH-IT' OR FECAL CONTAINMENT DEVICE |
Applicant |
MIDWEST MEDICAL CO. |
523 WILKINSON ST. |
CHELSEA,
MI
48118
|
|
Applicant Contact |
JOHN TEMPLE |
Correspondent |
MIDWEST MEDICAL CO. |
523 WILKINSON ST. |
CHELSEA,
MI
48118
|
|
Correspondent Contact |
JOHN TEMPLE |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 09/25/1987 |
Decision Date | 12/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|