Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K043044 |
Device Name |
ANTI-I.V. ENTERAL FEEDING SYSTEM |
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 | 11/04/2004 |
Decision Date | 05/06/2005 |
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
|
Recalls |
CDRH Recalls
|
|
|