FDA 510(k) Application Details - K100754

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K100754
Device Name	Syringe, Piston
Applicant	MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD ST PAUL, MN 55121-1385 US Other 510(k) Applications for this Company
Contact	THOMAS A LOPAC 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	03/17/2010
Decision Date	06/09/2010
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