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FDA 510(k)

Aqua Naina Plus Sterile Saline Solution

K-Number: K221263 · 2022-10-12

ApplicantChemtex USA, Inc.
Decision Date2022-10-12
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Aqua Naina Plus Sterile Saline Solution is a medical device manufactured by Chemtex USA, Inc.. It received FDA 510(k) clearance on 2022-10-12 under approval number K221263. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aqua Naina Plus Sterile Saline Solution?

Aqua Naina Plus Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Chemtex USA, Inc.. The 510(k) number is K221263.

When was Aqua Naina Plus Sterile Saline Solution approved by the FDA?

Aqua Naina Plus Sterile Saline Solution received FDA 510(k) clearance on 2022-10-12, under approval number K221263.

What company makes Aqua Naina Plus Sterile Saline Solution?

Aqua Naina Plus Sterile Saline Solution is manufactured by Chemtex USA, Inc..

What is the FDA product code for Aqua Naina Plus Sterile Saline Solution?

The FDA product code for Aqua Naina Plus Sterile Saline Solution is LPN.

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Other Devices by Chemtex USA, Inc.

K193441Aqua Naina Sterile Saline Solution

Related Devices (Code: LPN)

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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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