FDA 510(k) Application Details - K090436

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K090436
Device Name	Device, Anti-Snoring
Applicant	ORTHOPLANT DENTAL LAB 24-32 LEXINGTON DRIVE SUITE A31-A, LEVEL 3 BELLA VISTA, NEW SOUTH WALES 2153 AU Other 510(k) Applications for this Company
Contact	CHRISTOPHER KELLY 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	02/19/2009
Decision Date	04/16/2010
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