FDA 510(k) Application Details - K003219

Device Classification Name	Post, Root Canal   More FDA Info for this Device
510(K) Number	K003219
Device Name	Post, Root Canal
Applicant	HARALD NORDIN S.A 100 MAIN STREET; SUITE 120 CONCORD, MA 01742 US Other 510(k) Applications for this Company
Contact	JAMES DELANEY Other 510(k) Applications for this Contact
Regulation Number	872.3810   More FDA Info for this Regulation Number
Classification Product Code	ELR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2000
Decision Date	10/25/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review