Cleared Traditional

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)

K951003 · Kenex , Ltd. · Radiology

Apr 1995

Decision

47d

Days

Class 1

Risk

About This 510(k) Submission

K951003 is an FDA 510(k) clearance for the KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5), a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by Kenex , Ltd. (England, GB). The FDA issued a Cleared decision on April 3, 1995, 47 days after receiving the submission on February 15, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K951003 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1995
Decision Date	April 03, 1995
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF