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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K122718 B. Purpose for Submission: To obtain substantial equivalence for the
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What is to obtain substantial equivalence?
To obtain substantial equivalence is to demonstrate that a new product is substantially equivalent to a predicate product in terms of safety and effectiveness.
Who is required to file to obtain substantial equivalence?
Manufacturers of new products seeking market authorization are required to file to obtain substantial equivalence.
How to fill out to obtain substantial equivalence?
To obtain substantial equivalence, manufacturers must submit a premarket notification (510(k)) with the FDA.
What is the purpose of to obtain substantial equivalence?
The purpose of obtaining substantial equivalence is to ensure that new products meet the same safety and effectiveness standards as predicate products.
What information must be reported on to obtain substantial equivalence?
Manufacturers must provide information on the new product's design, intended use, materials, and performance characteristics.
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