FDA 510(k) Application Details - K173385

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K173385
Device Name	Syringe, Piston
Applicant	Micromedics, Inc. (d/b/a Nordson MEDICAL) 1270 Eagan Industrial Road, Suite 120 St. Paul, MN 55121 US Other 510(k) Applications for this Company
Contact	Kristi Brezinka 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	10/30/2017
Decision Date	11/30/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review