Bio Fluff System— 510(k) K201861

Substantially Equivalent

Gnali Bocia S.R.L.

FDA 510(k) clearance K201861 for Bio Fluff System, Substantially Equivalent on 2022-03-02. Applicant: Gnali Bocia S.R.L.. Device class: 2.

Clearance details

Applicant: Gnali Bocia S.R.L.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-06
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lumezzane, IT

Download summary PDF View on FDA.gov ↗

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