FDA 510(k) Application Details - K140144

Device Classification Name	Handle, Instrument, Dental   More FDA Info for this Device
510(K) Number	K140144
Device Name	Handle, Instrument, Dental
Applicant	CENTRIX, INC. 770 RIVER RD. SHELTON, CT 06484-5458 US Other 510(k) Applications for this Company
Contact	GREG MOREAU Other 510(k) Applications for this Contact
Regulation Number	872.4565   More FDA Info for this Regulation Number
Classification Product Code	EJB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2014
Decision Date	07/08/2014
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