FDA 510(k) Application Details - K170881

Device Classification Name	More FDA Info for this Device
510(K) Number	K170881
Device Name	ISP Safety Huber Needle Infusion Set
Applicant	Infusion Safety Products, Inc. 26 Victoria Court Keene, NH 03431 US Other 510(k) Applications for this Company
Contact	Alan P. Reid 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	03/24/2017
Decision Date	12/14/2017
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