FDA 510(k) Application Details - K141177

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K141177
Device Name	Barrier, Animal Source, Intraoral
Applicant	OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI 4620 71ST ST, BLDG 78 LUBBOCK, TX 79424 US Other 510(k) Applications for this Company
Contact	SHANE SHUTTLESWORTH 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	05/07/2014
Decision Date	09/15/2015
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