Cleared Traditional

UTK-DTE AUTILARY SHIELD

K954146 · Mallinckrodt Medical · Radiology
Dec 1995
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K954146 is an FDA 510(k) clearance for the UTK-DTE AUTILARY SHIELD, a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on December 6, 1995, 92 days after receiving the submission on September 5, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K954146 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1995
Decision Date December 06, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPY — Shield, Protective, Personnel
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500

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