FDA 510(k) Application Details - K112321

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K112321
Device Name	Unit, Operative Dental
Applicant	CARESTREAM HEALTH,INC. 1765 THE EXCHANGE ATLANTA, GA 30339 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER 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	08/12/2011
Decision Date	11/10/2011
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