FDA 510(k) Application Details - K172760

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K172760
Device Name	Device, Anti-Snoring
Applicant	Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 Cumming, GA 30028 US Other 510(k) Applications for this Company
Contact	Paul Hendrixson 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	09/13/2017
Decision Date	03/26/2018
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