FDA 510(k) Application Details - K083811

Device Classification Name	Injector, Jet, Mechanical-Powered   More FDA Info for this Device
510(K) Number	K083811
Device Name	Injector, Jet, Mechanical-Powered
Applicant	W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE BUERMOOS 5111 AT Other 510(k) Applications for this Company
Contact	JOHANN G SCHARL Other 510(k) Applications for this Contact
Regulation Number	872.4475   More FDA Info for this Regulation Number
Classification Product Code	EGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2008
Decision Date	01/14/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review