FDA 510(k) Application Details - K080032

Device Classification Name	Cement, Ear, Nose And Throat   More FDA Info for this Device
510(K) Number	K080032
Device Name	Cement, Ear, Nose And Throat
Applicant	ENVOY MEDICAL CORPORATION 5000 TOWNSHIP PARKWAY SAINT PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	BERNARD (BUD) HORWATH Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	NEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2008
Decision Date	02/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review