FDA 510(k) Application Details - K173188

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K173188
Device Name	Bone Grafting Material, Animal Source
Applicant	Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si 13516 KR Other 510(k) Applications for this Company
Contact	Hana Jung 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	10/02/2017
Decision Date	07/20/2018
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