FDA 510(k) Application Details - K123215

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K123215
Device Name	Cord, Retraction
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	KAREN KAKUNES 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	10/15/2012
Decision Date	02/05/2013
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