FDA 510(k) Application Details - K082249

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K082249
Device Name	Syringe, Cartridge
Applicant	MEIBACH TECH LTDA 1740 BROADWAY NEW YORK, NY 10019 US Other 510(k) Applications for this Company
Contact	STUART L FRIEDEL Other 510(k) Applications for this Contact
Regulation Number	872.6770   More FDA Info for this Regulation Number
Classification Product Code	EJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2008
Decision Date	12/31/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review