FDA 510(k) Application Details - K100160

Device Classification Name	Pillow,Cervical(For Mild Sleep Apnea)   More FDA Info for this Device
510(K) Number	K100160
Device Name	Pillow,Cervical(For Mild Sleep Apnea)
Applicant	SLEEP SPECIALISTS, LLC 1 CONGRESSIONAL DRIVE APT C GREENVILLE, DE 19807 US Other 510(k) Applications for this Company
Contact	HOWARD MANN Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	MYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2010
Decision Date	05/11/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review