FDA 510(k) Application Details - K993335

Device Classification Name	Reamer   More FDA Info for this Device
510(K) Number	K993335
Device Name	Reamer
Applicant	SYNTHES (USA) 1600 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	10/04/1999
Decision Date	06/12/2000
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