FDA 510(k) Application Details - K033815

Device Classification Name Bone Grafting Material, Animal Source

  More FDA Info for this Device
510(K) Number K033815
Device Name Bone Grafting Material, Animal Source
Applicant GEISTLICH-PHARMA
1301 K STREET NW
SUITE 600, EAST TOWER
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact PETER S REICHERTZ
Other 510(k) Applications for this Contact
Regulation Number 872.3930

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

  More FDA Info for this Product Code
Date Received 12/09/2003
Decision Date 01/15/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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