Cleared Traditional

2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)

K951004 · Kenex , Ltd. · Radiology

Apr 1995

Decision

54d

Days

Class 1

Risk

About This 510(k) Submission

K951004 is an FDA 510(k) clearance for the 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4), a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by Kenex , Ltd. (England, DE). The FDA issued a Cleared decision on April 10, 1995, 54 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	K951004 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1995
Decision Date	April 10, 1995
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF