Cleared Traditional

IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES

K933410 · Best Industries · Radiology
Dec 1994
Decision
533d
Days
Class 1
Risk

About This 510(k) Submission

K933410 is an FDA 510(k) clearance for the IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES, 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 December 30, 1994, 533 days after receiving the submission on July 15, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K933410 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1993
Decision Date December 30, 1994
Days to Decision 533 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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