The following data is part of a premarket notification filed by Nephron Pharmaceuticals Corp. with the FDA for Sodium Chloride Inhalation Solution, 3%, 7%, And 10%, Usp-4ml.
| Device ID | K120051 |
| 510k Number | K120051 |
| Device Name: | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML |
| 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 | 2012-01-06 |
| Decision Date | 2012-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30304879007308 | K120051 | 000 |
| 30304879003300 | K120051 | 000 |