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K131623 page 1 of 5 PM CRN 72014 JAN 1 Your Vascular Healthcare Partner 510(k) Summary, Section 5 Date of Preparation: April 26, 2013, This 510(k) Summary of safety and effectiveness information is
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This is a form used by the FDA to collect information about home healthcare products.
Manufacturers, distributors, and importers of home healthcare products are required to file k131623 with the FDA.
The form must be completed with information about the product, its intended use, and any adverse events.
The purpose of the form is to help the FDA monitor the safety and effectiveness of home healthcare products.
Information such as product details, adverse events, and manufacturing information must be reported on k131623.
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