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510(k) K214080

Device
Pentaflush
Applicant
PENTAFERTE ITALIA S.R.L.
510(k) number
K214080
Product code
NGT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-20
Date received
2021-12-27
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
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
Rosa Di Gioia
Address
Viale Piane Nocella, 23 Campli Teramo IT 64012 64012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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