Information required in a premarket notification 510(k) submission

21 CFR 807.87 lists the content a 510(k) premarket notification must contain: the device's proprietary and common name, its class, the intended use, a statement of substantial equivalence to a legally marketed predicate, proposed labels and labelling, compliance with any applicable performance standard, and a 510(k) Summary or Statement. Missing or inconsistent items here are a common trigger for an FDA Additional Information request, so this section defines the baseline completeness of a submission.