Device Classification Name |
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
|
510(k) Number |
K170110 |
Device Name |
Diana Medication Transfer Set |
Applicant |
ICU MEDICAL INC |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
Jason Ma |
Correspondent |
ICU MEDICAL INC |
600 N. Field Drive |
Lake Forest,
IL
60045
|
|
Correspondent Contact |
Jason Ma |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/12/2017 |
Decision Date | 08/10/2018 |
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
|