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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoral Cooling Device
510(k) Number K232917
Device Name Chemo Mouthpiece
Applicant
Chemo Mouthpiece, LLC
10 Railroad Avenue
Closter,  NJ  07624
Applicant Contact David Yoskowitz
Correspondent
MCRA
803 7th Street, NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Devjani Saha
Classification Product Code
QUA  
Date Received09/19/2023
Decision Date 01/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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