Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K061432 |
Device Name |
HOSPIRA ENTERAL FEEDING SET, MODEL 20640 |
Applicant |
HOSPIRA, INC. |
275 N. FIELD DR., BLDG. H-2 |
D-389 |
LAKE FOREST,
IL
60045 -5045
|
|
Applicant Contact |
DIANE RENNPFERD |
Correspondent |
HOSPIRA, INC. |
275 N. FIELD DR., BLDG. H-2 |
D-389 |
LAKE FOREST,
IL
60045 -5045
|
|
Correspondent Contact |
DIANE RENNPFERD |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/24/2006 |
Decision Date | 09/11/2006 |
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
|
|
|