Device Classification Name |
Tube, Feeding
|
510(k) Number |
K083791 |
Device Name |
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S |
Applicant |
CORPAK MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
STEPHANIE WASIELEWSKI |
Correspondent |
CORPAK MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
STEPHANIE WASIELEWSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/19/2008 |
Decision Date | 03/04/2009 |
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
|
|
|