Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K964066 |
Device Name |
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) |
Applicant |
C.R. BARD, INC. |
BARD ACCESS SYSTEMS |
5425 W. AMELIA EARHART DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
PEGGY KEIFFER |
Correspondent |
C.R. BARD, INC. |
BARD ACCESS SYSTEMS |
5425 W. AMELIA EARHART DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
PEGGY KEIFFER |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 10/10/1996 |
Decision Date | 03/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|