FDA 510(k) Application Details - K071555

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K071555
Device Name	Barrier, Animal Source, Intraoral
Applicant	ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 US Other 510(k) Applications for this Company
Contact	PATRICK R BILBO 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	06/07/2007
Decision Date	08/30/2007
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