Cleared Traditional

COATED TUNGSTEN EYESHIELD

K945515 · Medtec, Inc. · Radiology
Jun 1995
Decision
222d
Days
Class 1
Risk

About This 510(k) Submission

K945515 is an FDA 510(k) clearance for the COATED TUNGSTEN EYESHIELD, a Shield, Eye, Radiological (Class I — General Controls, product code IWS), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on June 19, 1995, 222 days after receiving the submission on November 9, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K945515 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1994
Decision Date June 19, 1995
Days to Decision 222 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