Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K081725 |
Device Name |
ENTERAL PUMP SET, MODEL 20-1010 |
Applicant |
VIASYS MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
STEPHANIE WASIELEWSKI |
Correspondent |
VIASYS MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
STEPHANIE WASIELEWSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/18/2008 |
Decision Date | 11/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|