FDA 510(k) Application Details - K012738

Device Classification Name	Motor, Surgical Instrument, Ac-Powered   More FDA Info for this Device
510(K) Number	K012738
Device Name	Motor, Surgical Instrument, Ac-Powered
Applicant	DEPUY ACROMED 325 PARAMOUNT DR. RAYNHAM, MA 02767-0350 US Other 510(k) Applications for this Company
Contact	KAREN F JURCZAK Other 510(k) Applications for this Contact
Regulation Number	878.4820   More FDA Info for this Regulation Number
Classification Product Code	GEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2001
Decision Date	11/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review