Passio Pump Drainage System— 510(k) K230319

Unknown

Bearpac Medical

FDA 510(k) clearance K230319 for Passio Pump Drainage System, Unknown on 2023-11-24. Applicant: Bearpac Medical. Device class: 2.

Clearance details

Applicant: Bearpac Medical
Product code: Code PNG
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 2023-02-06
Decision date: 2023-11-24
Decision: Unknown
Clearance type: Traditional
Location: Moultonborough, NH, 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.