FDA 510(k) Application Details - K232917

Device Classification Name	More FDA Info for this Device
510(K) Number	K232917
Device Name	Chemo Mouthpiece
Applicant	Chemo Mouthpiece, LLC 10 Railroad Avenue Closter, NJ 07624 US Other 510(k) Applications for this Company
Contact	David Yoskowitz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2023
Decision Date	01/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review