FDA 510(k) Application Details - K061175

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K061175
Device Name	Unit, Operative Dental
Applicant	SOTA PRECISION OPTICS, INC. 845 ARONSON LAKE COURT ROSWELL, GA 30075 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	04/27/2006
Decision Date	05/23/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review