FDA 510(k) Application Details - K130130

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K130130
Device Name	Device, Jaw Repositioning
Applicant	SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE BRADENTON, FL 34203 US Other 510(k) Applications for this Company
Contact	CAROLYN PRIMUS Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2013
Decision Date	08/26/2013
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