FDA 510(k) Application Details - K031540

Device Classification Name Handpiece, Direct Drive, Ac-Powered

  More FDA Info for this Device
510(K) Number K031540
Device Name Handpiece, Direct Drive, Ac-Powered
Applicant LARES RESEARCH, INC.
295 LOCKHEED AVE.
CHICO, CA 95973 US
Other 510(k) Applications for this Company
Contact JOHN DAHLGREN
Other 510(k) Applications for this Contact
Regulation Number 872.4200

  More FDA Info for this Regulation Number
Classification Product Code EKX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/16/2003
Decision Date 06/30/2003
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 Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact