FDA 510(k) Application Details - K042899

Device Classification Name	Reamer   More FDA Info for this Device
510(K) Number	K042899
Device Name	Reamer
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2004
Decision Date	03/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review