{"product_id":"fda-510k-k192579","title":"FDA 510(k) K192579, X-Guide Surgical Navigation System, by X-Nav Technologies, LLC","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eDental Stereotaxic Instrument\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK192579\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e X-Guide Surgical Navigation System\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e X-Nav Technologies, LLC\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e872.412\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003ePLV\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e09\/19\/2019\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 02\/03\/2020\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eDental\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eDental\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,275\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 524\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 751\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308063129764,"sku":"FDA510K192579","price":1800.98,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k192579","provider":"FOIA Document Source","version":"1.0","type":"link"}