FDA 510(k) Application Details - K964472

Device Classification Name	Prosthesis, Wrist, Carpal Trapezium   More FDA Info for this Device
510(K) Number	K964472
Device Name	Prosthesis, Wrist, Carpal Trapezium
Applicant	BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. PORT HURON, MI 48060 US Other 510(k) Applications for this Company
Contact	VALERIE GARDNER 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	11/07/1996
Decision Date	02/03/1997
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