FDA 510(k) Application Details - K072030

Device Classification Name Drill, Bone, Powered

  More FDA Info for this Device
510(K) Number K072030
Device Name Drill, Bone, Powered
Applicant SATELEC-ACTEON GROUP
124 GAITHER DRIVE , SUITE 140
MT LAUREL, NJ 08054 US
Other 510(k) Applications for this Company
Contact STEVE SALESKY
Other 510(k) Applications for this Contact
Regulation Number 872.4120

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

  More FDA Info for this Product Code
Date Received 07/24/2007
Decision Date 11/19/2007
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



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