FDA 510(k) Application Details - K073097

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K073097
Device Name	Barrier, Animal Source, Intraoral
Applicant	TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING ALACHUA, FL 32615 US Other 510(k) Applications for this Company
Contact	TRAVIS AROLA 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	11/01/2007
Decision Date	05/12/2008
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