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FDA 510(k)

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML

K-Number: K120051 · 2012-04-20

ApplicantNephron Pharmaceuticals Corp.
Decision Date2012-04-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML is the device name listed in this FDA 510(k) record. The listed applicant is Nephron Pharmaceuticals Corp.. It received FDA 510(k) clearance on 2012-04-20 under 510(k) number K120051. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML?

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML is a medical device that received FDA 510(k) clearance on 2012-04-20. The listed applicant is Nephron Pharmaceuticals Corp.. The 510(k) number is K120051.

When did SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML receive FDA 510(k) clearance?

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML received FDA 510(k) clearance on 2012-04-20, under 510(k) number K120051.

Who is the listed applicant for SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML?

The FDA 510(k) record lists Nephron Pharmaceuticals Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML?

The FDA product code for SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML is CAF.

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Other records listing Nephron Pharmaceuticals Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113033SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML

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Official Source

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