PneumoLiner— 510(k) K192898

Substantially Equivalent

Advanced Surgical Concepts

FDA 510(k) clearance K192898 for PneumoLiner, Substantially Equivalent on 2020-02-25. Applicant: Advanced Surgical Concepts.

Clearance details

Applicant: Advanced Surgical Concepts
Product code: Code PMU
Advisory panel: Obstetrics/Gynecology
Date received: 2019-10-11
Decision date: 2020-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bray, IE

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