PneumoLiner— 510(k) DEN150028

Unknown

Advanced Surgical Concepts, Ltd.

FDA 510(k) clearance DEN150028 for PneumoLiner, Unknown on 2016-04-07. Applicant: Advanced Surgical Concepts, Ltd.. Device class: 2.

Clearance details

Applicant: Advanced Surgical Concepts, Ltd.
Product code: Code PMU
Device class: Class 2
Regulation: 21 CFR 884.4050
Advisory panel: Obstetrics/Gynecology
Date received: 2015-06-19
Decision date: 2016-04-07
Decision: Unknown
Clearance type: Direct
Location: Bray, IE

View on FDA.gov ↗

Recent devices under product code PMU

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K192898 — PneumoLiner2020-02-25

More clearances from Advanced Surgical Concepts, Ltd.

K211234 — RedEx2021-09-17
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Data sourced from openFDA. This site is unofficial and independent of the FDA.