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510(k) K243840

Device
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
Applicant
Bridge TO Life
510(k) number
K243840
Product code
KDN
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-26
Date received
2024-12-13
Regulation
876.5880
Classification name
System, Perfusion, Kidney
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Mark Harper
Address
707 Skokie Blvd., Suite 340 Northbrook IL US 60062 60062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies2020-07-02
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