I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401— 510(k) K992963

Name: FDA 510(k) clearance K992963
Creator: U.S. Food and Drug Administration
Published: 1999-09-21

Substantially Equivalent

International Isotopes, Inc.

FDA 510(k) clearance K992963 for I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401, Substantially Equivalent on 1999-09-21. Applicant: International Isotopes, Inc.. Device class: 2.

Clearance details

Applicant: International Isotopes, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1999-09-02
Decision date: 1999-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

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