FDA 510(k) Application Details - K042691

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K042691
Device Name	Cement, Bone, Vertebroplasty
Applicant	COOK, INC. 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	JENNIFER J BOSLEY Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2004
Decision Date	11/08/2005
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