FDA 510(k) Application Details - K180838

Device Classification Name	Stimulator, Salivary System   More FDA Info for this Device
510(K) Number	K180838
Device Name	Stimulator, Salivary System
Applicant	Saliwell Ltd. 65 Hatamar St. Harutzim 6091700 IL Other 510(k) Applications for this Company
Contact	Ben Z. Beiski Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2018
Decision Date	11/06/2018
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