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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K234015
Device Name Caphosol® Artifical Saliva (32 doses sachet box)
Applicant
Eusa Pharma (Uk) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead,  GB HP2 4TZ
Applicant Contact Sandy Suh
Correspondent
Blackwell Device Consulting
3207 SE 156th Ave.
Portland,  OR  97236
Correspondent Contact Angela Blackwell
Classification Product Code
LFD  
Date Received12/19/2023
Decision Date 03/11/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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