PAL 7020 Console— 510(k) K244026

Name: FDA 510(k) clearance K244026
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Substantially Equivalent

Microaire Surgical Instruments, LLC

FDA 510(k) clearance K244026 for PAL 7020 Console, Substantially Equivalent on 2025-04-25. Applicant: Microaire Surgical Instruments, LLC. Device class: 2.

Clearance details

Applicant: Microaire Surgical Instruments, LLC
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2024-12-30
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, 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.