FDA 510(k) Application Details - DEN110009

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN110009
Device Name	RESTLESS LEG DEVICE
Applicant	MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEEPER'S 2210 ELK CREEK ROAD WATERFORD, PA 16441 US Other 510(k) Applications for this Company
Contact	MARY M SORG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2011
Decision Date	12/18/2013
Decision	DENG -
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review