21 CFR Subpart E
Premarket Notification Procedures
June 25, 2020
§
807.94
Format of a class III certification
§
807.95
Confidentiality of information
§
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
§
807.97
Misbranding by reference to premarket notification
§
807.100
FDA action on a premarket notification
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