FDA 510(k) Application Details - K982418

Device Classification Name	Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K982418
Device Name	Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Applicant	ENDOTEC, INC. 20 VALLEY ST. SOUTH ORANGE, NJ 07079 US Other 510(k) Applications for this Company
Contact	GEORGE MAKRIS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/1998
Decision Date	04/29/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review