FDA 510(k) Application Details - K250122

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K250122
Device Name	Device, Anti-Snoring
Applicant	Splintek Inc. 15555 W. 108th St. Lenexa, KS 66219 US Other 510(k) Applications for this Company
Contact	Thomas Brown 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	01/17/2025
Decision Date	05/19/2025
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