Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K133087 |
Device Name |
ABBVIE PEG |
Applicant |
ABBVIE INC. |
1 N. WAUKEGAN RD. |
NORTH CHICAGO,
IL
60064
|
|
Applicant Contact |
KATHERINE WORTLEY |
Correspondent |
ABBVIE INC. |
1 N. WAUKEGAN RD. |
NORTH CHICAGO,
IL
60064
|
|
Correspondent Contact |
KATHERINE WORTLEY |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 06/19/2014 |
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
|
|
|