← Product Code [KPY](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY) · K962622

# INTRA-ORAL THERMOPLASTIC SHIELD (K962622)

_Medtec, Inc. · KPY · Oct 1, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY/K962622

## Device Facts

- **Applicant:** Medtec, Inc.
- **Product Code:** [KPY](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY.md)
- **Decision Date:** Oct 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.6500
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY/K962622](https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY/K962622)

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