Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K894842 |
Device Name |
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM |
Applicant |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Applicant Contact |
JARBOE, PHD |
Correspondent |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Correspondent Contact |
JARBOE, PHD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/31/1989 |
Decision Date | 09/12/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|