# Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/addendum-to-guidance-on-premarket-notification-510k-submissions-for-sterilizers-intended-for-use-in-health-care-facilities/a2dbc601-f93b-4c12-8753-3d2a932a7855

> FDA guidance document: Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities. Issue date: September 18, 1995. Get complete insights and analysis.

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## Details

- Title: Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities
- Communication Type: Guidance Document
- Product Type: Medical Devices
- Office Name: Center for Devices and Radiological Health
- Issue Date: 1995-09-18
- Docket Number: FDA-2020-D-0957

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