Omnia Medical VBR— 510(k) K191778

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K191778 for Omnia Medical VBR, Substantially Equivalent on 2019-08-28. Applicant: Omnia Medical, LLC. Device class: 2.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2019-07-02
Decision date: 2019-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Morgantown,, WV, 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.