FDA 510(k) Application Details - K041858

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K041858
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124-9432 US Other 510(k) Applications for this Company
Contact	ED BOEHMER 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	07/09/2004
Decision Date	10/05/2004
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