Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K082241 |
Device Name |
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 |
Applicant |
DALE MEDICAL PRODUCTS, INC. |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
DALE MEDICAL PRODUCTS, INC. |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/07/2008 |
Decision Date | 10/30/2008 |
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
|
|
|