FDA 510(k) Application Details - K121253

Device Classification Name Drills, Burrs, Trephines & Accessories (Compound, Powered)

  More FDA Info for this Device
510(K) Number K121253
Device Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant ADEOR MEDICAL TECHNOLOGIES GMBH
KIRCHPLATZ 1
PULLACH 82049 DE
Other 510(k) Applications for this Company
Contact FABIO VON ZEPPELIN
Other 510(k) Applications for this Contact
Regulation Number 882.4305

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

  More FDA Info for this Product Code
Date Received 04/25/2012
Decision Date 07/17/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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