FDA 510(k) Application Details - K113126

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K113126
Device Name	Device, Anti-Snoring
Applicant	GERGENS ORTHODONTIC LAB 11825 State Route 40 Ste 101 Dunlap, IL 61525 US Other 510(k) Applications for this Company
Contact	KAREN E WARDEN, PHD 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	10/24/2011
Decision Date	07/17/2013
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