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FDA 510(k)

Caphosol® Artifical Saliva (32 doses sachet box)

K-Number: K234015 · 2024-03-11

ApplicantEusa Pharma (Uk) Limited
Decision Date2024-03-11
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

Caphosol® Artifical Saliva (32 doses sachet box) is the device name listed in this FDA 510(k) record. The listed applicant is Eusa Pharma (Uk) Limited. It received FDA 510(k) clearance on 2024-03-11 under 510(k) 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. The listed applicant is Eusa Pharma (Uk) Limited. The 510(k) number is K234015.

When did Caphosol® Artifical Saliva (32 doses sachet box) receive FDA 510(k) clearance?

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

Who is the listed applicant for Caphosol® Artifical Saliva (32 doses sachet box)?

The FDA 510(k) record lists Eusa Pharma (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

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 records listing Eusa Pharma (Uk) Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162167Caphosol Artifical Saliva Tablets

Related Devices (Code: LFD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253778Allday Moisturizing RinseElevate Oral CareK250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLCK202689Dentilube SprayOxy2plus, LLCK203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company

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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