Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K080328 |
Device Name |
MPS ACACIA ENTERAL FEEDING TUBE |
Applicant |
MPS ACACIA |
785 CHALLENGER ST. |
BREA,
CA
92821
|
|
Applicant Contact |
FERGIE FERGUSON |
Correspondent |
MPS ACACIA |
785 CHALLENGER ST. |
BREA,
CA
92821
|
|
Correspondent Contact |
FERGIE FERGUSON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/07/2008 |
Decision Date | 05/14/2008 |
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
|
|
|