FDA 510(k) Application Details - K983285

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K983285
Device Name	Unit, Operative Dental
Applicant	ENGLE DENTAL SYSTEMS 4115 24TH AVE SUITE A P.O. BOX 725 FOREST GROVE, OR 97116 US Other 510(k) Applications for this Company
Contact	MARVIN FOX Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/1998
Decision Date	11/04/1998
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