FDA 510(k) Application Details - K053516

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K053516
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	NELSON J GENDUSA Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2005
Decision Date	01/26/2006
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