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FDA 510(k)

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

K-Number: K170270 · 2017-06-23

ApplicantLs Scientific Inc. D.B.A. Kse Scientific
Decision Date2017-06-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is a medical device manufactured by Ls Scientific Inc. D.B.A. Kse Scientific. It received FDA 510(k) clearance on 2017-06-23 under approval number K170270. 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 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Ls Scientific Inc. D.B.A. Kse Scientific. The 510(k) number is K170270.

When was Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline approved by the FDA?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2017-06-23, under approval number K170270.

What company makes Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is manufactured by Ls Scientific Inc. D.B.A. Kse Scientific.

What is the FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

The FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline 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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