FDA 510(k) Application Details - K043322

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K043322
Device Name	Syringe, Cartridge
Applicant	HAGER WORLDWIDE, INC. 4 LINCOLN ST ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	JAMES DELANEY 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	12/02/2004
Decision Date	07/21/2005
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