Cleared Special

IMPLANT GUIDANCE SYSTEM APPLICATOR SET

K020015 · Nucletron Corp. · Radiology
Mar 2002
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K020015 is an FDA 510(k) clearance for the IMPLANT GUIDANCE SYSTEM APPLICATOR SET, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on March 13, 2002, 69 days after receiving the submission on January 3, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K020015 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2002
Decision Date March 13, 2002
Days to Decision 69 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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