Cleared Traditional

K934549 - ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
(FDA 510(k) Clearance)

K934549 · Victoreen, Inc. · Radiology device

Feb 1994

Decision

150d

Days

Class 1

Risk

K934549 is an FDA 510(k) clearance for the ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD. This device is classified as a Holder, Syringe, Lead (Class I - General Controls, product code IWR).

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 19, 1994, 150 days after receiving the submission on September 22, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K934549 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 22, 1993
Decision Date	February 19, 1994
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement