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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k120664 B. Purpose for Submission: Modification of a previously cleared device (k023639) to add
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Start by accessing the decision summary form provided by the Accessdata platform.
02
Fill in all the required fields, such as the case details, date, and case number.
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Provide a concise summary of the decision, outlining the main points and conclusions.
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Please note that the specific users who need decision summaries may vary depending on the context and the organization utilizing the Accessdata platform.
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Decision summary - accessdata is a document providing a summary of decisions made regarding access to data.
Those individuals or organizations who have made decisions related to access to data are required to file decision summary - accessdata.
Decision summary - accessdata can be filled out by providing a brief description of the decision made, the date of the decision, and any relevant details.
The purpose of decision summary - accessdata is to document and summarize decisions made regarding access to data for future reference.
Decision summary - accessdata must include details such as the decision made, date of the decision, individuals involved in the decision, and any supporting documentation.
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