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FDA 510(k)

0.9% Sodium Chloride Injection, USP

K-Number: K173348 · 2018-06-21

ApplicantMedline Industries, Inc.
Decision Date2018-06-21
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-06-21 under approval number K173348. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.9% Sodium Chloride Injection, USP?

0.9% Sodium Chloride Injection, USP is a medical device that received FDA 510(k) clearance on 2018-06-21. It is manufactured by Medline Industries, Inc.. The 510(k) number is K173348.

When was 0.9% Sodium Chloride Injection, USP approved by the FDA?

0.9% Sodium Chloride Injection, USP received FDA 510(k) clearance on 2018-06-21, under approval number K173348.

What company makes 0.9% Sodium Chloride Injection, USP?

0.9% Sodium Chloride Injection, USP is manufactured by Medline Industries, Inc..

What is the FDA product code for 0.9% Sodium Chloride Injection, USP?

The FDA product code for 0.9% Sodium Chloride Injection, USP is NGT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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