NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE— 510(k) K964647

Name: FDA 510(k) clearance K964647
Creator: U.S. Food and Drug Administration
Published: 1997-02-10

Substantially Equivalent

North American Scientific, Inc.

FDA 510(k) clearance K964647 for NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE, Substantially Equivalent on 1997-02-10. Applicant: North American Scientific, Inc.. Device class: 2.

Clearance details

Applicant: North American Scientific, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1996-11-20
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, 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.