CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE— 510(k) K062384

Name: FDA 510(k) clearance K062384
Creator: U.S. Food and Drug Administration
Published: 2006-11-09

Substantially Equivalent

Isoray, Inc.

FDA 510(k) clearance K062384 for CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE, Substantially Equivalent on 2006-11-09. Applicant: Isoray, Inc.. Device class: 2.

Clearance details

Applicant: Isoray, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2006-08-15
Decision date: 2006-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Richland, WA, US

Download summary PDF View on FDA.gov ↗

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