FDA 510(k) Application Details - K080430

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K080430
Device Name	Screw, Fixation, Intraosseous
Applicant	STORZ AM MARK GMBH EMMINGER STR. 39 EMMINGEN-LIPTINGEN 78576 DE Other 510(k) Applications for this Company
Contact	FRANZ MENEAN Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2008
Decision Date	11/21/2008
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