Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities

Name: Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities
Creator: Food and Drug Administration
Keywords: 510k,guidances,health-care-facilities,notification,pre-market,pre-market-notification

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

March 1, 1993

Last updated

March 17, 2020

Description

A guidance document on premarket notification for sterilizers used in healthcare facilities.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities

Updated on March 17, 2020

pdf (843.4KB)

URL: https://www.fda.gov/media/72458/download
Permalink: https://data.openrid.co/en/datasets/r/c0a01f10-ba4e-4c79-b80c-b8ca829df10a
MIME Type: application/pdf

Created on: March 1, 1993
Modified on: March 17, 2020

Size: 843.4KB

Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

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