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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
Model 0487-9301, 0487-9302
Device Name SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
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 Received10/12/2011
Decision Date 06/19/2012
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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