FDA 510(k) Application Details - K113839

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K113839
Device Name	Cord, Retraction
Applicant	PARKELL, INC. 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US Other 510(k) Applications for this Company
Contact	DANIEL R SCHECHTER 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	12/28/2011
Decision Date	04/12/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review