FDA 510(k) Application Details - K191618

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K191618
Device Name	Device, Anti-Snoring
Applicant	Michael D Williams DDS PA 10991 SW 42ND PL Davie, FL 33328 US Other 510(k) Applications for this Company
Contact	Michael Williams Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2019
Decision Date	12/11/2019
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