FDA 510(k) Application Details - K962774

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K962774
Device Name	Screw, Fixation, Intraosseous
Applicant	OSTEOMED CORP. 3150 PREMIER DR. #110 IRVING, TX 75063 US Other 510(k) Applications for this Company
Contact	JAMES D LAFFERTY 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	07/16/1996
Decision Date	10/10/1997
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