Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K900336 |
Device Name |
V SET |
Applicant |
GO MEDICAL INDUSTRIES PTY. LTD. |
200 CHURCHILL AVE. |
SUBIACO, PERTH,
AU
6008
|
|
Applicant Contact |
DAVID CAPES |
Correspondent |
GO MEDICAL INDUSTRIES PTY. LTD. |
200 CHURCHILL AVE. |
SUBIACO, PERTH,
AU
6008
|
|
Correspondent Contact |
DAVID CAPES |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/23/1990 |
Decision Date | 10/04/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|