Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

Name: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers
Creator: Food and Drug Administration
Keywords: 510k,disinfectants,fda,guidances,industry,notification,pre-market,pre-market-notification,reviewer,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

January 2, 2000

Last updated

March 18, 2020

Description

This document is a guidance for industry and FDA reviewers on the content and format of premarket notification submissions for liquid chemical sterilants/high level disinfectants.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

1 Main file

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

Updated on March 18, 2020

pdf (238.2KB)

URL: https://www.fda.gov/media/72097/download
Permalink: https://data.openrid.co/en/datasets/r/68c77ed5-5975-4c72-9ae7-df0d2bcbdb0e
MIME Type: application/pdf

Created on: January 2, 2000
Modified on: March 18, 2020

Size: 238.2KB

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed