Cleared Special

PROGUIDE NEEDLE SET

K060349 · Nucletron Corporation · Radiology
Mar 2006
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K060349 is an FDA 510(k) clearance for the PROGUIDE NEEDLE SET, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on March 10, 2006, 28 days after receiving the submission on February 10, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K060349 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2006
Decision Date March 10, 2006
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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