Cleared Traditional

THERMOPLASTIC SHIELD

K954456 · Medtec, Inc. · Radiology
Dec 1995
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K954456 is an FDA 510(k) clearance for the THERMOPLASTIC SHIELD, a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 21, 1995, 87 days after receiving the submission on September 25, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K954456 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1995
Decision Date December 21, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPY — Shield, Protective, Personnel
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500

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