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510(k) K191195

Device
PiccGuard
Applicant
PiccGuard LLC
510(k) number
K191195
Product code
PZW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-03
Date received
2019-05-03
Regulation
880.5970
Classification name
Catheter Access Cover, Tamper-resistant
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Katie Justus
Address
2677 Sarah Ln. Beloit WI US 53511 53511

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company2022-05-23

Legacy Summary#

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FDA Review#

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