Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K012113 |
Device Name |
INDWELLING FECAL MANAGEMENT SYSTEM |
Applicant |
BOWEL MANAGEMENT SYSTEMS, LLC |
7992 CASTEWAY DR. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
COLLEEN J HITTLE |
Correspondent |
BOWEL MANAGEMENT SYSTEMS, LLC |
7992 CASTEWAY DR. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
COLLEEN J HITTLE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 07/06/2001 |
Decision Date | 05/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|