Belzer UW® Cold Storage Solution (BTLBUW-001)— 510(k) K243384

Name: FDA 510(k) clearance K243384
Creator: U.S. Food and Drug Administration
Published: 2025-03-31

Substantially Equivalent

Bridge TO Life

FDA 510(k) clearance K243384 for Belzer UW® Cold Storage Solution (BTLBUW-001), Substantially Equivalent on 2025-03-31. Applicant: Bridge TO Life. Device class: 2.

Clearance details

Applicant: Bridge TO Life
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-31
Decision date: 2025-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.