FDA 510(k) Application Details - K092513

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K092513
Device Name	Powder, Porcelain
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	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2009
Decision Date	10/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review