FDA 510(k) Application Details - K043411

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K043411
Device Name	Washer, Bolt Nut
Applicant	RESOFIX, INC. 5349 RED LEAF COURT OVIEDO, FL 32765 US Other 510(k) Applications for this Company
Contact	CARL KNOBLOCH Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2004
Decision Date	02/17/2005
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