FDA 510(k) Application Details - K972118

Device Classification Name Alloy, Metal, Base

  More FDA Info for this Device
510(K) Number K972118
Device Name Alloy, Metal, Base
Applicant AALBA DENT, INC.
1819 SO. MAY STREET, 2F
CHICAGO, IL 60608 US
Other 510(k) Applications for this Company
Contact ROBERT W BAUER
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 06/05/1997
Decision Date 08/15/1997
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