Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K854566 |
Device Name |
TERUMO SURFLO ETFE I.V. CATHETER |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
HAROLD JACOBY |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
HAROLD JACOBY |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/05/1985 |
Decision Date | 01/23/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|