Cleared Traditional

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001

K041715 · Nucletron Corp. · Radiology
Mar 2005
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K041715 is an FDA 510(k) clearance for the INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001, 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 24, 2005, 274 days after receiving the submission on June 23, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K041715 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2004
Decision Date March 24, 2005
Days to Decision 274 days
Submission Type Traditional
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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