# Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/guidance-document-for-the-preparation-of-premarket-notification-510k-applications-for-heating-and-cooling-devices/0e6cd838-ebdc-46a1-9353-767d2f7702f3

> FDA guidance document: Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices. Issue date: July 25, 1995. Get complete insights and analysis.

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## Details

- Title: Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 1995-07-25
- Last Changed: 2020-03-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

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