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Premarket Notification Procedures | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter H
Part 807
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.