Cleared Traditional

NUCLEAR ASSOCIATES GLASSERS

K934362 · Victoreen, Inc. · Radiology
Nov 1993
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K934362 is an FDA 510(k) clearance for the NUCLEAR ASSOCIATES GLASSERS, a Shield, Eye, Radiological (Class I — General Controls, product code IWS), submitted by Victoreen, Inc. (Solon, US). The FDA issued a Cleared decision on November 12, 1993, 65 days after receiving the submission on September 8, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K934362 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1993
Decision Date November 12, 1993
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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