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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) 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. The listed applicant is Medline Industries, Inc.. The 510(k) number is K173348.

When did 0.9% Sodium Chloride Injection, USP receive FDA 510(k) clearance?

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

Who is the listed applicant for 0.9% Sodium Chloride Injection, USP?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: NGT)

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.

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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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