FDA 510(k) Application Details - K090005

Device Classification Name Implant, Endosseous, Root-Form

  More FDA Info for this Device
510(K) Number K090005
Device Name Implant, Endosseous, Root-Form
Applicant BRANEMARK INTEGRATION AB
LILLA BOMMEN 1
GOTEBORG SE-411 04 SE
Other 510(k) Applications for this Company
Contact AGNETA SVENSSON
Other 510(k) Applications for this Contact
Regulation Number 872.3640

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

  More FDA Info for this Product Code
Date Received 01/02/2009
Decision Date 05/19/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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