FDA 510(k) Application Details - K974399

Device Classification Name Bone Grafting Material, Synthetic

  More FDA Info for this Device
510(K) Number K974399
Device Name Bone Grafting Material, Synthetic
Applicant GEISTLICH-PHARMA
WASHINGTON SQUARE
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON, DC 20036 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 LYC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/21/1997
Decision Date 09/16/1998
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