Cleared Traditional

Caphosol? Artifical Saliva (32 doses sachet box)

K234015 · Eusa Pharma (Uk) Limited · Dental

Mar 2024

Decision

83d

Days

—

Risk

About This 510(k) Submission

K234015 is an FDA 510(k) clearance for the Caphosol? Artifical Saliva (32 doses sachet box), a Saliva, Artificial, submitted by Eusa Pharma (Uk) Limited (Hemel Hempstead, GB). The FDA issued a Cleared decision on March 11, 2024, 83 days after receiving the submission on December 19, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number	K234015 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2023
Decision Date	March 11, 2024
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF