FDA 510(k) Application Details - K103399

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K103399
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	ASEPTICO, INC. 8333 216TH ST., S.E. WOODINVILLE, WA 98072 US Other 510(k) Applications for this Company
Contact	CHERIE TREGONING Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2010
Decision Date	02/28/2011
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