FDA 510(k) Application Details - K013383

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K013383
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOMEDICAL IMPLANT TECHNOLOGY, INC. 206 KING ST. ST. CATHARINES, ON L2R 3J7 CA Other 510(k) Applications for this Company
Contact	RODNEY J SHAUGHNESSY Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2001
Decision Date	01/10/2002
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