FDA 510(k) Application Details - K151543

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K151543
Device Name	Syringe, Piston
Applicant	Micromedics Inc. (d/b/a Nordson Medical) 1270 Eagan Industrial Rd, Suite 120 St.Paul, MN 55121 US Other 510(k) Applications for this Company
Contact	Amy L Peterson 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	06/08/2015
Decision Date	07/07/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review