Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K010703 |
Device Name |
INTER-VIAL |
Applicant |
DUOJECT MEDICAL SYSTEMS, INC. |
50 RUE DE GASPE COMPLEX B-5 |
BROMONT, QC.,
CA
J2L 2N8
|
|
Applicant Contact |
DANIEL MACDONALD |
Correspondent |
DUOJECT MEDICAL SYSTEMS, INC. |
50 RUE DE GASPE COMPLEX B-5 |
BROMONT, QC.,
CA
J2L 2N8
|
|
Correspondent Contact |
DANIEL MACDONALD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/09/2001 |
Decision Date | 06/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|