FDA 510(k) Application Details - K033045

Device Classification Name Alloy, Metal, Base

  More FDA Info for this Device
510(K) Number K033045
Device Name Alloy, Metal, Base
Applicant AMERICAN GREEN DENT. MFG, INC.
3432 E. 14TH STREET
LOS ANGELES, CA 90023 US
Other 510(k) Applications for this Company
Contact ANDREW ROWE
Other 510(k) Applications for this Contact
Regulation Number 872.3710

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

  More FDA Info for this Product Code
Date Received 09/29/2003
Decision Date 12/23/2003
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