Cleared Special

KUSKE BREAST APPLICATOR SET, MODEL 189.006

K022635 · Nucletron Corporation · Radiology
Sep 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K022635 is an FDA 510(k) clearance for the KUSKE BREAST APPLICATOR SET, MODEL 189.006, 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 September 6, 2002, 29 days after receiving the submission on August 8, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K022635 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2002
Decision Date September 06, 2002
Days to Decision 29 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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