Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K103109 |
Device Name |
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE |
Applicant |
C.R. BARD INC |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
DENNIS SALZMANN |
Correspondent |
C.R. BARD INC |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
DENNIS SALZMANN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/21/2010 |
Decision Date | 12/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|