Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K142816 |
Device Name |
AbbVie J |
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 | 09/29/2014 |
Decision Date | 01/14/2015 |
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 |
Yes
|
|
|