# Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/guidance-on-premarket-notification-510k-submissions-for-automated-endoscope-washers-washerdisinfectors-and-disinfectors-intended-for-use-in-health-care-facilities/b1565cbf-b93e-4897-b812-8ef664f08d50

> FDA guidance document: Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities. Issue date: August 01, 1993. Get complete insights and analysis.

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## Details

- Title: Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
- 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: 1993-08-01
- 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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