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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 807
Subpart E - Subpart E—Premarket Notification Procedures
§ 807.81 - When a premarket notification submission is required.
§ 807.85 - Exemption from premarket notification.
§ 807.87 - Information required in a premarket notification submission.
§ 807.90 - Format of a premarket notification submission.
§ 807.92 - Content and format of a 510(k) summary.
§ 807.93 - Content and format of a 510(k) statement.
§ 807.94 - Format of a class III certification.
§ 807.95 - Confidentiality of information.
§ 807.97 - Misbranding by reference to premarket notification.
§ 807.100 - FDA action on a premarket notification.
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