FDA 510(k) Application Details - K152322

Device Classification Name	More FDA Info for this Device
510(K) Number	K152322
Device Name	Resolve 2.0
Applicant	DENALI CORPORATION 134 OLD WASHINGTON STREET HANOVER, MA 02339 US Other 510(k) Applications for this Company
Contact	Jan G Stannard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PME Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2015
Decision Date	12/16/2015
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