BRACHYTHERAPY STRAND DEVICE— 510(k) K040339

Name: FDA 510(k) clearance K040339
Creator: U.S. Food and Drug Administration
Published: 2004-04-08

Substantially Equivalent

Bebig Isotopen-Und Medizintechnik GmbH

FDA 510(k) clearance K040339 for BRACHYTHERAPY STRAND DEVICE, Substantially Equivalent on 2004-04-08. Applicant: Bebig Isotopen-Und Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Bebig Isotopen-Und Medizintechnik GmbH
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2004-02-11
Decision date: 2004-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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