FDA 510(k)

Caphosol® Artifical Saliva (32 doses sachet box)

K-Number: K234015 · 2024-03-11

Decision Date2024-03-11

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

Caphosol® Artifical Saliva (32 doses sachet box) is a medical device manufactured by Eusa Pharma (Uk) Limited. It received FDA 510(k) clearance on 2024-03-11 under approval number K234015. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caphosol® Artifical Saliva (32 doses sachet box)?

Caphosol® Artifical Saliva (32 doses sachet box) is a medical device that received FDA 510(k) clearance on 2024-03-11. It is manufactured by Eusa Pharma (Uk) Limited. The 510(k) number is K234015.

When was Caphosol® Artifical Saliva (32 doses sachet box) approved by the FDA?

Caphosol® Artifical Saliva (32 doses sachet box) received FDA 510(k) clearance on 2024-03-11, under approval number K234015.

What company makes Caphosol® Artifical Saliva (32 doses sachet box)?

Caphosol® Artifical Saliva (32 doses sachet box) is manufactured by Eusa Pharma (Uk) Limited.

What is the FDA product code for Caphosol® Artifical Saliva (32 doses sachet box)?

The FDA product code for Caphosol® Artifical Saliva (32 doses sachet box) is LFD.

Other Devices by Eusa Pharma (Uk) Limited

K162167Caphosol Artifical Saliva Tablets

Related Devices (Code: LFD)

K163029Hydris Oral RinseBiopharm Consult, LLC K163476LubricityYou First Services, Incorporated K162167Caphosol Artifical Saliva TabletsEusa Pharma (Uk) Limited K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc. K173808VoutiaJeffrey Ward Cash, Dds K181134GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.