Caphosol® Artifical Saliva (32 doses sachet box)
FDA 510(k) K234015 · Eusa Pharma (Uk) Limited
510(k) numberK234015
Submission
- Device name
- Caphosol® Artifical Saliva (32 doses sachet box)
- Applicant
- Eusa Pharma (Uk) Limited
Hemel Hempstead, GB - Received
- December 19, 2023
- Decision date
- March 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFD – Saliva, Artificial
- Device class
- Unclassified
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| K202689 | Dentilube SprayLFD · Traditional | Oxy2plus, LLC | 09/03/2021SE |
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 09/02/2020SE |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional | Oralabs, Inc. | 11/21/2019SE |
| K190144 | MucoPEGLFD · Traditional | Sunbio, Inc. | 11/05/2019SE |
| K181194 | SmartMouth DryMouth Oral RinseLFD · Traditional | Triumph Pharmaceuticals, Inc. | 02/15/2019SE |
More from Triumph Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162167 | Caphosol Artifical Saliva TabletsLFD · Traditional | 03/31/2017SE |
Questions and answers
When was Caphosol® Artifical Saliva (32 doses sachet box) cleared by the FDA?
Caphosol® Artifical Saliva (32 doses sachet box) (K234015) received a 510(k) decision of Substantially Equivalent on March 11, 2024, 83 days after the submission was received.
What is the product code of K234015?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.