FDA 510(k) Application Details - K021131

Device Classification Name Varnish, Cavity

  More FDA Info for this Device
510(K) Number K021131
Device Name Varnish, Cavity
Applicant CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
Other 510(k) Applications for this Company
Contact JOHN DISCKO
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 04/08/2002
Decision Date 09/26/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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