CIVA SHEET PD-103— 510(k) K140490

Substantially Equivalent

Civatech Oncology, Inc.

FDA 510(k) clearance K140490 for CIVA SHEET PD-103, Substantially Equivalent on 2014-08-29. 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: 2014-02-27
Decision date: 2014-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Airy, MD, 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.