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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K120051
Device Name SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
Applicant
NEPHRON PHARMACEUTICALS CORP.
4121 34TH ST. S.W.
ORLANDO,  FL  32811 -6475
Applicant Contact MARCUS JULIANO
Correspondent
NEPHRON PHARMACEUTICALS CORP.
4121 34TH ST. S.W.
ORLANDO,  FL  32811 -6475
Correspondent Contact MARCUS JULIANO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/06/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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