FDA 510(k) Application Details - K161762

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K161762
Device Name	Barrier, Animal Source, Intraoral
Applicant	COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 US Other 510(k) Applications for this Company
Contact	Perry W. Guinn 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	06/27/2016
Decision Date	01/13/2017
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