Cleared Traditional

ROYAL MARSDEN GOLD GRAIN GUN

K940119 · Best Industries · Radiology
Dec 1994
Decision
354d
Days
Class 1
Risk

About This 510(k) Submission

K940119 is an FDA 510(k) clearance for the ROYAL MARSDEN GOLD GRAIN GUN, a Shield, Eye, Radiological (Class I — General Controls, product code IWS), submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on December 30, 1994, 354 days after receiving the submission on January 10, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K940119 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1994
Decision Date December 30, 1994
Days to Decision 354 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWS — Shield, Eye, Radiological
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500