FDA 510(k) Application Details - K191195

Device Classification Name	More FDA Info for this Device
510(K) Number	K191195
Device Name	PiccGuard
Applicant	PiccGuard LLC 2677 Sarah Lane Beloit, WI 53511 US Other 510(k) Applications for this Company
Contact	Katie Justus Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2019
Decision Date	01/03/2020
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