FDA 510(k) Application Details - K080939

Device Classification Name	Handpiece, Rotary Bone Cutting   More FDA Info for this Device
510(K) Number	K080939
Device Name	Handpiece, Rotary Bone Cutting
Applicant	W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE BUERMOOS 5111 AT Other 510(k) Applications for this Company
Contact	GABRIELE WIENBECK Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	KMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2008
Decision Date	07/29/2008
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