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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT C O M BI A TI N TEMPLATE N O A. 510(k) Number: K110923 B. Purpose for Submission: To determine substantial equivalence
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What is to determine substantial equivalence?
To determine substantial equivalence is to compare a new product to an existing product to ensure they are similar enough to be considered equivalent.
Who is required to file to determine substantial equivalence?
Manufacturers or distributors of new products are required to file to determine substantial equivalence.
How to fill out to determine substantial equivalence?
To fill out to determine substantial equivalence, manufacturers or distributors must provide detailed information on the new product and compare it to an existing product.
What is the purpose of to determine substantial equivalence?
The purpose of to determine substantial equivalence is to ensure the safety and efficacy of new products entering the market.
What information must be reported on to determine substantial equivalence?
Manufacturers or distributors must report information on the composition, design, and intended use of the new product.
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