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FDA 510(k)

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP

K-Number: K173276 · 2018-07-02

ApplicantMedline Industries, Inc.
Decision Date2018-07-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-07-02 under approval number K173276. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP?

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP is a medical device that received FDA 510(k) clearance on 2018-07-02. It is manufactured by Medline Industries, Inc.. The 510(k) number is K173276.

When was Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP approved by the FDA?

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP received FDA 510(k) clearance on 2018-07-02, under approval number K173276.

What company makes Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP?

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP?

The FDA product code for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP is FRO. This falls under the Anesthesiology category.

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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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