FDA 510(k) Application Details - K050188

Device Classification Name	Block, Bite   More FDA Info for this Device
510(K) Number	K050188
Device Name	Block, Bite
Applicant	EPISAFE MEDICAL DEVICES, LTD. 291 Hillside Avenue Somerset, MA 02726 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB Other 510(k) Applications for this Contact
Regulation Number	882.5070   More FDA Info for this Regulation Number
Classification Product Code	JXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2005
Decision Date	04/27/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review