FDA 510(k) Application Details - K011450

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K011450
Device Name	Material, Impression
Applicant	NORTHEAST RESINS & SILICONES, LLC. 698 ANDREA CT CHESHIRE, CT 06410 US Other 510(k) Applications for this Company
Contact	SIVANANDA S JADA Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2001
Decision Date	06/13/2001
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