FDA 510(k) Application Details - K983242

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K983242
Device Name	Unit, Operative Dental
Applicant	SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. NORTH ATTLEBORO, MA 02760-4153 US Other 510(k) Applications for this Company
Contact	SHEILA HAMEON-HEYER 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	09/16/1998
Decision Date	12/11/1998
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