Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K912702 |
FOIA Releasable 510(k) |
K912702
|
Device Name |
PLASTIC ATTACHABLE DUAL PORT |
Applicant |
DAVOL, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
ANN MARTIN |
Correspondent |
DAVOL, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
ANN MARTIN |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 06/19/1991 |
Decision Date | 09/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|