← Product Code [KPY](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY) · K953610

# AUKULYTE (K953610)

_Aukland Medical Plastics, Inc. · KPY · Sep 26, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY/K953610

## Device Facts

- **Applicant:** Aukland Medical Plastics, Inc.
- **Product Code:** [KPY](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY.md)
- **Decision Date:** Sep 26, 1995
- **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/K953610](https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/KPY/K953610)

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