FDA 510(k) Application Details - K151945

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K151945
Device Name	Dam, Rubber
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	872.6300   More FDA Info for this Regulation Number
Classification Product Code	EIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2015
Decision Date	02/18/2016
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