SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML

Nebulizer (direct Patient Interface)

NEPHRON PHARMACEUTICALS CORP.

The following data is part of a premarket notification filed by Nephron Pharmaceuticals Corp. with the FDA for Sodium Chlorde Inhalation Solution, 0.9% Usp-3ml.

Pre-market Notification Details

• Device ID: K113033
• 510k Number: K113033
• Device Name: SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
• Classification: Nebulizer (direct Patient Interface)
• Applicant: NEPHRON PHARMACEUTICALS CORP. 4121 34TH ST. S.W. Orlando, FL 32811 -6475
• Contact: Marcus Juliano
• Correspondent: Marcus Juliano; NEPHRON PHARMACEUTICALS CORP. 4121 34TH ST. S.W. Orlando, FL 32811 -6475
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-12
• Decision Date: 2012-06-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30304879302014	K113033	000
30304879301338	K113033	000
30304879301031	K113033	000
00860011790310	K113033	000