Cleared Traditional

BEST INDUSTRIES CARTRIDGE & GUN

K924290 · Best Industries · Radiology
Jun 1993
Decision
287d
Days
Class 1
Risk

About This 510(k) Submission

K924290 is an FDA 510(k) clearance for the BEST INDUSTRIES CARTRIDGE & GUN, a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ), submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on June 4, 1993, 287 days after receiving the submission on August 21, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K924290 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1992
Decision Date June 04, 1993
Days to Decision 287 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWJ — System, Applicator, Radionuclide, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5650

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