Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff

Name: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff
Creator: Food and Drug Administration
Keywords: 510k,fda,guidances,industry,natural,notification,pre-market,pre-market-notification,skin,submissions,testing

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

January 12, 1999

Last updated

March 18, 2020

Description

This document is a guidance for industry and FDA reviewers/staff on premarket notification submissions for testing skin sensitization to chemicals in natural rubber products.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff

Updated on March 18, 2020

pdf (40.5KB)

URL: https://www.fda.gov/media/71835/download
Permalink: https://data.openrid.co/en/datasets/r/a4222a53-f162-41c9-bfad-e7264c3e3b42
MIME Type: application/pdf

Created on: January 12, 1999
Modified on: March 18, 2020

Size: 40.5KB

Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

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