UROMED BRACHYTHERAPHY IODINE-125 SOURCES— 510(k) K982226

Name: FDA 510(k) clearance K982226
Creator: U.S. Food and Drug Administration
Published: 1999-05-13

Substantially Equivalent

Uromed Corp.

FDA 510(k) clearance K982226 for UROMED BRACHYTHERAPHY IODINE-125 SOURCES, Substantially Equivalent on 1999-05-13. Applicant: Uromed Corp.. Device class: 2.

Clearance details

Applicant: Uromed Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1998-06-24
Decision date: 1999-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, 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.