FDA 510(k) Application Details - K001385

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K001385
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. RUTHERFORD, NJ 07070-2584 US Other 510(k) Applications for this Company
Contact	JENNIFER A DAUDELIN Other 510(k) Applications for this Contact
Regulation Number	888.3170   More FDA Info for this Regulation Number
Classification Product Code	KWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2000
Decision Date	07/27/2000
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