PERF-GEN Pulsatile Perfusion Solution— 510(k) K221386

Name: FDA 510(k) clearance K221386
Creator: U.S. Food and Drug Administration
Published: 2022-06-14

Substantially Equivalent

Institut Georges Lopez

FDA 510(k) clearance K221386 for PERF-GEN Pulsatile Perfusion Solution, Substantially Equivalent on 2022-06-14. Applicant: Institut Georges Lopez. Device class: 2.

Clearance details

Applicant: Institut Georges Lopez
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2022-05-13
Decision date: 2022-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lissieu, FR

Download summary PDF View on FDA.gov ↗

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