Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K081311 |
Device Name |
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER |
Applicant |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
JIHYUN KIM |
Correspondent |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
JIHYUN KIM |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 05/09/2008 |
Decision Date | 06/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|