Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K063118 |
Device Name |
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE |
Applicant |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
SUSAN SCOTT |
Correspondent |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
SUSAN SCOTT |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/11/2006 |
Decision Date | 02/13/2007 |
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
|
|
|