FDA 510(k) Application Details - K973056

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K973056
Device Name	Screw, Fixation, Intraosseous
Applicant	BICON, INC. 1153 CENTRE ST., SUITE 21 BOSTON, MA 02130 US Other 510(k) Applications for this Company
Contact	VINCENT J MORGAN 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	08/15/1997
Decision Date	11/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review