FDA 510(k) Application Details - K160377

Device Classification Name Varnish, Cavity

  More FDA Info for this Device
510(K) Number K160377
Device Name Varnish, Cavity
Applicant Vericom Co., Ltd.
48 Toegyegongdan 1-gil,
Chuncheon-si 200-944 KR
Other 510(k) Applications for this Company
Contact Myung-Hwan Oh
Other 510(k) Applications for this Contact
Regulation Number 872.3260

  More FDA Info for this Regulation Number
Classification Product Code LBH
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/10/2016
Decision Date 12/02/2016
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact