FDA 510(k), K123215, VISCOSTAT CLEAR

510(K) Number: K123215
Device Name: VISCOSTAT CLEAR
Manufacturer: KAREN KAKUNES
Device Classification Name: Cord, Retraction
Regulation Number: MVL
Classification Product Code: KXA
Date Received: 10/15/2012
Decision Date: 02/05/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental