Cleared Special

VALENCIA SKIN APPLICATOR SET, MODEL: 189.701

K073107 · Nucletron Corporation · Radiology
Dec 2007
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K073107 is an FDA 510(k) clearance for the VALENCIA SKIN APPLICATOR SET, MODEL: 189.701, 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 December 7, 2007, 35 days after receiving the submission on November 2, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K073107 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2007
Decision Date December 07, 2007
Days to Decision 35 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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