FDA 510(k) Application Details - K042458

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite   More FDA Info for this Device
510(K) Number	K042458
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant	A.M. SURGICAL, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	LXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2004
Decision Date	10/07/2004
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