FDA 510(k) Application Details - K193212

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K193212
Device Name	Bone Grafting Material, Animal Source
Applicant	DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 US Other 510(k) Applications for this Company
Contact	Susan Pileggi 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	11/21/2019
Decision Date	09/10/2020
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