FDA 510(k) Application Details - K150454

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K150454
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	PERFLEX 7 GIBOREY ISRAEL ST., INDUSTRIAL AREA POLEG NETANYA 4250407 IL Other 510(k) Applications for this Company
Contact	RAY KELLY Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2015
Decision Date	05/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review