FDA 510(k) Application Details - K063769

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K063769
Device Name	Screw, Fixation, Intraosseous
Applicant	ALPHA-BIO TEC LTD 5335 WISCONSIN AVE. NW SUITE 440 WASHINGTON, DC 20015 US Other 510(k) Applications for this Company
Contact	DANIEL J MANELLI 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	12/20/2006
Decision Date	03/30/2007
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