Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K973561 |
Device Name |
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M |
Applicant |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEANNE M CUSH |
Correspondent |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEANNE M CUSH |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/19/1997 |
Decision Date | 05/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|