FDA 510(k) Application Details - K032686

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K032686
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 AUSTIN, TX 78754-3832 US Other 510(k) Applications for this Company
Contact	PETER STRZEPA 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	08/29/2003
Decision Date	10/22/2003
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