Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K000087 |
Device Name |
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR |
Applicant |
THE KENDAL CO. |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048 -1108
|
|
Applicant Contact |
REGINA YEH |
Correspondent |
THE KENDAL CO. |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048 -1108
|
|
Correspondent Contact |
REGINA YEH |
Regulation Number | 880.5200 |
Classification Product Code |
|
Date Received | 01/12/2000 |
Decision Date | 03/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|