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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
Original Applicant
NEPHRON PHARMACEUTICALS CORP.
4121 34th st. s.w.
orlando,  FL  32811 6475
Original Contact marcus juliano
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/06/2012
Decision Date 04/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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