FDA 510(k) Application Details - K994298

Device Classification Name	Handpiece, Rotary Bone Cutting   More FDA Info for this Device
510(K) Number	K994298
Device Name	Handpiece, Rotary Bone Cutting
Applicant	FRIADENT GMBH 21911 ERIE LN. LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON 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	12/21/1999
Decision Date	02/18/2000
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