Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K962554 |
Device Name |
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE |
Applicant |
ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215
|
|
Applicant Contact |
DANIEL HAMILTON |
Correspondent |
ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215
|
|
Correspondent Contact |
DANIEL HAMILTON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 07/01/1996 |
Decision Date | 11/07/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|