Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K192414 |
Device Name |
Praxiject 0.9% NaCl |
Applicant |
MedXL Inc. |
285 Av Labrosse |
Pointe-Claire,
CA
H9R 1A3
|
|
Applicant Contact |
Premala Premanathan |
Correspondent |
MedXL Inc. |
285 Av Labrosse |
Pointe-Claire,
CA
H9R 1A3
|
|
Correspondent Contact |
Premala Premanathan |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/04/2019 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|