FDA 510(k) Application Details - K071028

Device Classification Name	Splint, Denis Brown   More FDA Info for this Device
510(K) Number	K071028
Device Name	Splint, Denis Brown
Applicant	EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D WEST BERLIN, NJ 08091 US Other 510(k) Applications for this Company
Contact	LARRY PICCIANO Other 510(k) Applications for this Contact
Regulation Number	890.3675   More FDA Info for this Regulation Number
Classification Product Code	ITN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2007
Decision Date	05/01/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review