Device Classification Name |
Container, I.V.
|
510(k) Number |
K250459 |
Device Name |
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution |
Applicant |
Technoflex SAS. |
ZA de Bassilour |
Bidart,
FR
64210
|
|
Applicant Contact |
Dominique Saint Ellier |
Correspondent |
mdi Consutants Inc. |
55 Northern Blvd, Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Vaibhav Rajal |
Regulation Number | 880.5025 |
Classification Product Code |
|
Date Received | 02/18/2025 |
Decision Date | 04/18/2025 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|