FDA 510(k) Application Details - K073336

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

  More FDA Info for this Device
510(K) Number K073336
Device Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
Other 510(k) Applications for this Company
Contact EMILY E VALERIO
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 11/28/2007
Decision Date 01/04/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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