FDA 510(k) Application Details - K092530

Device Classification Name	Wire, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K092530
Device Name	Wire, Fixation, Intraosseous
Applicant	RUSSELL B. WALTHER 6026 MARTEL AVENUE DALLAS, TX 75206 US Other 510(k) Applications for this Company
Contact	RUSSELL B WALTHER Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2009
Decision Date	04/02/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review