FDA 510(k) Application Details - K192429

Device Classification Name	Device, Electrical Dental Anesthesia   More FDA Info for this Device
510(K) Number	K192429
Device Name	Device, Electrical Dental Anesthesia
Applicant	Synapse Dental 67 Phenix Avenue Cranston, RI 02910 US Other 510(k) Applications for this Company
Contact	Cosmo Haralambidis Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2019
Decision Date	01/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review