Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K232523 |
Device Name |
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% |
Applicant |
Mankind Pharma Limited |
208, Okhla Industrial Estate |
Phase-3 |
New Delhi,
IN
110020
|
|
Applicant Contact |
Rajender Singh |
Correspondent |
Lifestar Pharma LLC (a Mankind Group Company) |
1200 MacArthur Blvd. |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Parimal Upadhyay |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/18/2023 |
Decision Date | 04/10/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|