FDA 510(k) Application Details - K000311

Device Classification Name	Post, Root Canal   More FDA Info for this Device
510(K) Number	K000311
Device Name	Post, Root Canal
Applicant	COLTENE/WHALEDENT INC. 750 CORPORATE DR. MAHWAH, NJ 07430-2009 US Other 510(k) Applications for this Company
Contact	H.J. VOGELSTEIN 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	02/01/2000
Decision Date	03/14/2000
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