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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 12, 1999

January 31, 2025

Center for Devices and Radiological Health

087c8cf4-129b-48b0-9e77-367fa3b3896e

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