FDA 510(k) Application Details - K011666

Device Classification Name	Tester, Pulp   More FDA Info for this Device
510(K) Number	K011666
Device Name	Tester, Pulp
Applicant	HEATSHIELD, INC. 110 LOCKWOOD AVE. SUITE 400 NEW ROCHELLE, NY 10801 US Other 510(k) Applications for this Company
Contact	WILLIAM A PLOUMIS Other 510(k) Applications for this Contact
Regulation Number	872.1720   More FDA Info for this Regulation Number
Classification Product Code	EAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2001
Decision Date	08/06/2001
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