Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Number868.5630
Classification Product Code
CAF  
Date Received08/18/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-