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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: k123935 B. Purpose for Submission: Modified device to include Bluetooth
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Decision summary - accessdata is a summary report that outlines key decisions made during a specified period of time with regards to accessing data.
Any individual or organization that has made significant decisions related to accessing data is required to file a decision summary - accessdata.
Decision summary - accessdata can be filled out by documenting the decisions made, the rationale behind them, the impact of the decisions, and any follow-up actions required.
The purpose of decision summary - accessdata is to provide a clear record of key decisions made regarding data access, ensuring transparency and accountability.
Information such as the date of the decision, the individuals involved, the decision made, the rationale for the decision, and any follow-up actions required must be reported on decision summary - accessdata.
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