Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K950153 |
Device Name |
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES |
Applicant |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Applicant Contact |
AHMAD SAJADI |
Correspondent |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Correspondent Contact |
AHMAD SAJADI |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/17/1995 |
Decision Date | 08/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|