Cleared Traditional

INTRA-ORAL THERMOPLASTIC SHIELD

K962622 · Medtec, Inc. · Radiology
Oct 1996
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K962622 is an FDA 510(k) clearance for the INTRA-ORAL 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 October 1, 1996, 88 days after receiving the submission on July 5, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K962622 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1996
Decision Date October 01, 1996
Days to Decision 88 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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