FDA 510(k) Application Details - K132401

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K132401
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	OSSTELL AB 901 KING STREET SUITE 101 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	CHERITA JAMES 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	08/01/2013
Decision Date	04/09/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review