FDA 510(k) Application Details - K171735

Device Classification Name	More FDA Info for this Device
510(K) Number	K171735
Device Name	PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
Applicant	C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Jeremy Tidwell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2017
Decision Date	08/08/2017
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