FDA 510(k) Application Details - K081025

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K081025
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	REMI SCIENCES, INC. 745 BENT CREEK DRIVE LITITZ, PA 17543 US Other 510(k) Applications for this Company
Contact	SANJIV H NAIDU Other 510(k) Applications for this Contact
Regulation Number	888.3810   More FDA Info for this Regulation Number
Classification Product Code	KXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2008
Decision Date	11/21/2008
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