FDA 510(k) Application Details - K083695

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K083695
Device Name	Cord, Retraction
Applicant	PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. PLYMOUTH MEETING, PA 19462 US Other 510(k) Applications for this Company
Contact	VINCENT D'ALESSANDRO Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MVL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2008
Decision Date	04/28/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review