FDA 510(k) Application Details - K102307

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K102307
Device Name	Barrier, Animal Source, Intraoral
Applicant	GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	EUNKYUNG SON 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	08/16/2010
Decision Date	05/04/2011
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