FDA 510(k) Application Details - K103179

Device Classification Name	More FDA Info for this Device
510(K) Number	K103179
Device Name	PRELUDE II TOUNGE SUSPENSION SYSTEM
Applicant	SIESTA MEDICAL, INC. 101 CHURCH STREET SUITE 3 LOS GATOS, CA 95030 US Other 510(k) Applications for this Company
Contact	MICHAEL KOLBER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2010
Decision Date	12/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review