FDA 510(k) Application Details - K082116

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K082116
Device Name	Cord, Retraction
Applicant	SATELEC 124 GAITHER DRIVE SUITE 140 MT. LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI 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	07/28/2008
Decision Date	12/17/2008
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