FDA 510(k)

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

K-Number: K191378 · 2019-09-15

Decision Date2019-09-15

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe 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 2019-09-15 under 510(k) number K191378. 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, Pre-filled COP Syringe?

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is a medical device that received FDA 510(k) clearance on 2019-09-15. The listed applicant is Medline Industries, Inc.. The 510(k) number is K191378.

When did 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe receive FDA 510(k) clearance?

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe received FDA 510(k) clearance on 2019-09-15, under 510(k) number K191378.

Who is the listed applicant for 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe?

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, Pre-filled COP Syringe?

The FDA product code for 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is NGT.

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Related Devices (Code: 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.