IMAGYN 125 I SEED, MODEL IS 125— 510(k) K982421

Name: FDA 510(k) clearance K982421
Creator: U.S. Food and Drug Administration
Published: 1998-07-31

Substantially Equivalent

International Isotopes, Inc.

FDA 510(k) clearance K982421 for IMAGYN 125 I SEED, MODEL IS 125, Substantially Equivalent on 1998-07-31. Applicant: International Isotopes, Inc.. Device class: 2.

Clearance details

Applicant: International Isotopes, Inc.
Product code: Code IWG
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1998-07-13
Decision date: 1998-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

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