FDA 510(k) Application Details - K053643

Device Classification Name Abutment, Implant, Dental, Endosseous

  More FDA Info for this Device
510(K) Number K053643
Device Name Abutment, Implant, Dental, Endosseous
Applicant LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA, MN 55318-3015 US
Other 510(k) Applications for this Company
Contact BRIAN SMEKAL
Other 510(k) Applications for this Contact
Regulation Number 872.3630

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

  More FDA Info for this Product Code
Date Received 12/30/2005
Decision Date 01/23/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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