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Mere Dental GmbH Richard Hunter Principal Washington Regulatory Consultants, LLC 5616 Mariola PI NE Albuquerque, Minnesota 87111December 18, 2018Re: K173124 Trade/Device Name: PEEK Biosolution Regulation
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Peek 510kdocx is a document filed with the FDA for medical device clearance.
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Peek 510kdocx should be filled out with detailed information about the medical device and its intended use.
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Information such as device description, intended use, and performance data must be reported on peek 510kdocx.
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