FDA 510(k) Application Details - K980428

Device Classification Name	Prosthesis, Elbow, Constrained, Cemented   More FDA Info for this Device
510(K) Number	K980428
Device Name	Prosthesis, Elbow, Constrained, Cemented
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	DEBORAH M MATARAZZO R.N., B.S.N. Other 510(k) Applications for this Contact
Regulation Number	888.3150   More FDA Info for this Regulation Number
Classification Product Code	JDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/1998
Decision Date	05/05/1998
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