Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K120375 |
Device Name |
MED-RX PATIENT DELIVERY SET |
Applicant |
BENLAN INC |
2760 BRIGHTON RD |
OAKVILLE,
CA
L6H 5T4
|
|
Applicant Contact |
CHERYL BROWN |
Correspondent |
BENLAN INC |
2760 BRIGHTON RD |
OAKVILLE,
CA
L6H 5T4
|
|
Correspondent Contact |
CHERYL BROWN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 06/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|