More-Cell-System— 510(k) K212659

Name: FDA 510(k) clearance K212659
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Substantially Equivalent

Agency For Medical Innovations GmbH

FDA 510(k) clearance K212659 for More-Cell-System, Substantially Equivalent on 2021-11-10. Applicant: Agency For Medical Innovations GmbH. Device class: 2.

Clearance details

Applicant: Agency For Medical Innovations GmbH
Product code: Code PMU
Device class: Class 2
Regulation: 21 CFR 884.4050
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-23
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirch, AT

Download summary PDF View on FDA.gov ↗

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