FDA 510(k) Application Details - K091424

Device Classification Name Bone Grafting Material, Animal Source

  More FDA Info for this Device
510(K) Number K091424
Device Name Bone Grafting Material, Animal Source
Applicant OSTA TECHNOLOGIES
845 ARONSON LAKE COURT
ROSWELL, GA 30075 US
Other 510(k) Applications for this Company
Contact JAY MANSOUR
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 05/13/2009
Decision Date 08/18/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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