FDA 510(k) Application Details - K041595

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K041595
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	BIOPRO, INC. 17 SEVENTEENTH ST. PORT HURON, MI 48060 US Other 510(k) Applications for this Company
Contact	DAVID MARK Other 510(k) Applications for this Contact
Regulation Number	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2004
Decision Date	11/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review