CIVASTRING PD-103— 510(k) K082159

Substantially Equivalent

Civatech Oncology, Inc.

FDA 510(k) clearance K082159 for CIVASTRING PD-103, Substantially Equivalent on 2008-09-30. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mebane, NC, US
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