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510(k) K234015

Caphosol® Artifical Saliva (32 doses sachet box) by Eusa Pharma (Uk) Limited — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2024
Date Received
December 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Eusa Pharma (Uk) Limited

  • K162167 — Caphosol Artifical Saliva Tablets (March 31, 2017)

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