FDA 510(k) Application Details - K100389

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K100389
Device Name	Handpiece, Air-Powered, Dental
Applicant	HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. PLACENTIA, CA 92870 US Other 510(k) Applications for this Company
Contact	TINA STEFFAINE-OAK Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2010
Decision Date	08/12/2010
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