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FDA 510(k)

SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML

K-Number: K113033 · 2012-06-19

ApplicantNephron Pharmaceuticals Corp.
Decision Date2012-06-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML 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 2012-06-19 under 510(k) number K113033. 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 CHLORDE INHALATION SOLUTION, 0.9% USP-3ML?

SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML is a medical device that received FDA 510(k) clearance on 2012-06-19. The listed applicant is Nephron Pharmaceuticals Corp.. The 510(k) number is K113033.

When did SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML receive FDA 510(k) clearance?

SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML received FDA 510(k) clearance on 2012-06-19, under 510(k) number K113033.

Who is the listed applicant for SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML?

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 CHLORDE INHALATION SOLUTION, 0.9% USP-3ML?

The FDA product code for SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML 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.

K120051SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML

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Official Source

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