FDA 510(k) Application Details - K192042

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K192042
Device Name	Barrier, Animal Source, Intraoral
Applicant	Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen CH-6110 CH Other 510(k) Applications for this Company
Contact	Marco Steiner Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2019
Decision Date	08/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review