FDA 510(k) Application Details - K040070

Device Classification Name	Prosthesis, Wrist, Carpal Trapezium   More FDA Info for this Device
510(K) Number	K040070
Device Name	Prosthesis, Wrist, Carpal Trapezium
Applicant	ARTIMPLANT AB 719 A STREET NE WASHINGTON, DC 20002 US Other 510(k) Applications for this Company
Contact	MARIE MARLOW Other 510(k) Applications for this Contact
Regulation Number	888.3770   More FDA Info for this Regulation Number
Classification Product Code	KYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2004
Decision Date	09/21/2004
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