Magnetic Surgical System— 510(k) K191762

Name: FDA 510(k) clearance K191762
Creator: U.S. Food and Drug Administration
Published: 2020-04-01

Substantially Equivalent

Levita Magnetics International Corp

FDA 510(k) clearance K191762 for Magnetic Surgical System, Substantially Equivalent on 2020-04-01. Applicant: Levita Magnetics International Corp. Device class: 2.

Clearance details

Applicant: Levita Magnetics International Corp
Product code: Code PNL
Device class: Class 2
Regulation: 21 CFR 878.4815
Advisory panel: General, Plastic Surgery
Date received: 2019-07-01
Decision date: 2020-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

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