FDA 510(k) Application Details - K061297

Device Classification Name Motor, Drill, Pneumatic

  More FDA Info for this Device
510(K) Number K061297
Device Name Motor, Drill, Pneumatic
Applicant THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
Other 510(k) Applications for this Company
Contact JAMES CARBONE
Other 510(k) Applications for this Contact
Regulation Number 882.4370

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

  More FDA Info for this Product Code
Date Received 05/09/2006
Decision Date 01/26/2007
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