FDA 510(k) Application Details - K171254

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K171254
Device Name	Syringe, Cartridge
Applicant	Advanced Technology and Capital, Inc. 5 Sylvan Ave. Englewood Cliffs, NJ 07632 US Other 510(k) Applications for this Company
Contact	Alexander Lee Other 510(k) Applications for this Contact
Regulation Number	872.6770   More FDA Info for this Regulation Number
Classification Product Code	EJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2017
Decision Date	11/16/2017
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