FDA 510(k) Application Details - K101609

Device Classification Name	Orthopedic Manual Surgical Instrument   More FDA Info for this Device
510(K) Number	K101609
Device Name	Orthopedic Manual Surgical Instrument
Applicant	KOROS USA, INC. 610 FLINN AVE. MOORPARK, CA 93021 US Other 510(k) Applications for this Company
Contact	TIBOR KOROS Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	LXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2010
Decision Date	12/09/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review