AIR BARRIER SYSTEM (ABS)— 510(k) K123006

Substantially Equivalent

Nimbic Systems, Inc.

FDA 510(k) clearance K123006 for AIR BARRIER SYSTEM (ABS), Substantially Equivalent on 2013-12-20. Applicant: Nimbic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Nimbic Systems, Inc.
Product code: Code ORC
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Date received: 2012-09-27
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.