npSIMS Negative Pressure Surgical Incision Management System (npSIMS)— 510(k) K201400

Name: FDA 510(k) clearance K201400
Creator: U.S. Food and Drug Administration
Published: 2021-08-23

Substantially Equivalent

Aatru Medical, LLC

FDA 510(k) clearance K201400 for npSIMS Negative Pressure Surgical Incision Management System (npSIMS), Substantially Equivalent on 2021-08-23. Applicant: Aatru Medical, LLC. Device class: 2.

Clearance details

Applicant: Aatru Medical, LLC
Product code: Code QPX
Device class: Class 2
Regulation: 21 CFR 878.4683
Advisory panel: General, Plastic Surgery
Date received: 2020-05-28
Decision date: 2021-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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