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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. SW
Orlando,  FL  32811 -6475
Applicant Contact MARCUS JULIANO
Correspondent
Nephron Pharmaceuticals Corp.
4121 34th St. SW
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
Predetermined Change
Control Plan Authorized		 No
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