FDA 510(k) Application Details - K964261

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K964261
Device Name	Screw, Fixation, Intraosseous
Applicant	SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA J SILVESTRI 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	10/25/1996
Decision Date	04/11/1997
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