FDA 510(k) Application Details - K974392

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K974392
Device Name	Screw, Fixation, Intraosseous
Applicant	BIOVISION GMBH 2320 FARADAY AVE. CARLSBAD, CA 92008-7216 US Other 510(k) Applications for this Company
Contact	FOSTER BOOP 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	11/21/1997
Decision Date	01/30/1998
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