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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 K113033
Device Name SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
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 Received10/12/2011
Decision Date 06/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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