FDA 510(k) Application Details - K022887

Device Classification Name	Prosthesis, Toe, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K022887
Device Name	Prosthesis, Toe, Constrained, Polymer
Applicant	OSTEOMED CORP. 3750 REALTY RD. ADDISON, TX 75001-4311 US Other 510(k) Applications for this Company
Contact	DAWN T HOLDEMAN Other 510(k) Applications for this Contact
Regulation Number	888.3720   More FDA Info for this Regulation Number
Classification Product Code	KWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2002
Decision Date	11/26/2002
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