FDA 510(k) Application Details - K080549

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K080549
Device Name	Coating, Filling Material, Resin
Applicant	PARKELL, INC. 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US Other 510(k) Applications for this Company
Contact	DANIEL R SCHECHTER, ESQ Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2008
Decision Date	05/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review