Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K201415 |
Device Name |
Vial2Bag Advanced 20mm Admixture Device |
Applicant |
West Pharmaceutical Services AZ, Inc. |
14677 North 74th Street |
Scottsdale,
AZ
85260
|
|
Applicant Contact |
Elena Mack |
Correspondent |
West Pharmaceutical Services, Inc. |
530 Herman O West Drive |
Exton,
PA
19341
|
|
Correspondent Contact |
Di Wu |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/29/2020 |
Decision Date | 10/21/2020 |
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
|
|
|