Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K891087 |
Device Name |
TERUMO SURFLO(R) I.V. CATHETER |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GEORGE S MOMODA |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GEORGE S MOMODA |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/01/1989 |
Decision Date | 06/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|