Cleared Traditional

FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095

K983338 · Nucletron Corp. · Radiology
Apr 1999
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K983338 is an FDA 510(k) clearance for the FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095, 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 April 20, 1999, 209 days after receiving the submission on September 23, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K983338 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1998
Decision Date April 20, 1999
Days to Decision 209 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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