FDA 510(k) Application Details - K052248

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K052248
Device Name	Plate, Fixation, Bone
Applicant	HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 MIAMI, FL 33176 US Other 510(k) Applications for this Company
Contact	ERNESTO HERNANDEZ Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2005
Decision Date	09/14/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review