Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K924250 |
Device Name |
PLASTIC LOW PROFILE SUBCUTANEOUS PORT |
Applicant |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
JACK SPEER |
Correspondent |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
JACK SPEER |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 08/24/1992 |
Decision Date | 10/04/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|