FDA 510(k) Application Details - K984357

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite   More FDA Info for this Device
510(K) Number	K984357
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant	IMMEDICA, INC. 100 PASSAIC AVE. CHATHAM, NJ 07928-2848 US Other 510(k) Applications for this Company
Contact	ROY BOGERT 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	12/07/1998
Decision Date	03/04/1999
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