Device Classification Name |
device, intravascular catheter securement
|
510(k) Number |
K924369 |
Device Name |
ILS(TM) - INVASIVE LINE SEPARATOR |
Applicant |
2-RN CORP. |
P.O. BOX 361183 |
MELBOURNE,
FL
32936
|
|
Applicant Contact |
JUDITH V SIMPSON |
Correspondent |
2-RN CORP. |
P.O. BOX 361183 |
MELBOURNE,
FL
32936
|
|
Correspondent Contact |
JUDITH V SIMPSON |
Regulation Number | 880.5210
|
Classification Product Code |
|
Date Received | 08/28/1992 |
Decision Date | 02/05/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|