FDA 510(k) Application Details - K152064

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K152064
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	COREY JASEPH 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	07/24/2015
Decision Date	09/24/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review