FDA 510(k) Application Details - K171295

Device Classification Name	More FDA Info for this Device
510(K) Number	K171295
Device Name	ULab Systems Treatment Planning Software
Applicant	ULab Systems, Inc. 101 Jefferson Drive, Suite 212A Menlo Park, CA 95025 US Other 510(k) Applications for this Company
Contact	Charlie Wen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2017
Decision Date	01/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review