Cleared Traditional

ACRYSTEEL BLOCKING TRAY

K954705 · Medtec, Inc. · Radiology
Jan 1996
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K954705 is an FDA 510(k) clearance for the ACRYSTEEL BLOCKING TRAY, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on January 5, 1996, 85 days after receiving the submission on October 12, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K954705 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1995
Decision Date January 05, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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