FDA 510(k) Application Details - K200772

Device Classification Name	More FDA Info for this Device
510(K) Number	K200772
Device Name	ULab Systems uDesign Software
Applicant	ULab Systems, Inc. 1820 Gateway Drive, Suite 300 San Mateo, CA 94404 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	03/25/2020
Decision Date	06/23/2020
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