FDA 510(k) Application Details - K083457

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K083457
Device Name	Syringe, Piston
Applicant	HASELMEIER GMBH 30833 NORTHWESTERN HIGHWAY SUITE 121 FARMINGTON HILL, MI 48334 US Other 510(k) Applications for this Company
Contact	STEPHEN J GOLDNER, JD, RAC Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2008
Decision Date	02/13/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review