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510(k) K120051

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML by Nephron Pharmaceuticals Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2012
Date Received
January 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Nephron Pharmaceuticals Corp.

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