CivaDerm— 510(k) K191324

Substantially Equivalent

Civatech Oncology, Inc.

FDA 510(k) clearance K191324 for CivaDerm, Substantially Equivalent on 2019-09-20. Applicant: Civatech Oncology, Inc.. Device class: 2.

Clearance details

Applicant: Civatech Oncology, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2019-05-16
Decision date: 2019-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.