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510(k) K162167

Caphosol Artifical Saliva Tablets by Eusa Pharma (Uk) Limited — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2017
Date Received
August 3, 2016
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

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