Device Classification Name |
gastrointestinal tubes with enteral specific connectors
|
510(k) Number |
K142012 |
Device Name |
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS |
Applicant |
CORPAK MEDSYSTEMS |
1001 ASBURY DR. |
BUFFALO GROVE,
IL
60089
|
|
Applicant Contact |
STEPHANIE WASIELEWKI |
Correspondent |
CORPAK MEDSYSTEMS |
1001 ASBURY DR. |
BUFFALO GROVE,
IL
60089
|
|
Correspondent Contact |
STEPHANIE WASIELEWKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 07/24/2014 |
Decision Date | 11/20/2014 |
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
|