FDA 510(k) Application Details - K173594

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K173594
Device Name	Bone Grafting Material, Animal Source
Applicant	Institut Straumann AG Peter Merian Weg 12 Basel CH-4002 CH Other 510(k) Applications for this Company
Contact	Christelle Gerspach-Gasser 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	11/21/2017
Decision Date	10/19/2018
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