FDA 510(k) Application Details - K082058

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K082058
Device Name	Barrier, Animal Source, Intraoral
Applicant	COOK BIOTECH, INC. 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	DAVID J COLLETTE 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	07/21/2008
Decision Date	10/02/2008
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