FDA 510(k) Application Details - K973180

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K973180
Device Name	Screw, Fixation, Intraosseous
Applicant	IMTEC CORP. 2401 NORTH COMMERCE ARDMORE, OK 73401 US Other 510(k) Applications for this Company
Contact	M. K. PATTERSON 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	08/25/1997
Decision Date	11/18/1997
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