{"product_id":"fda-510k-k182971","title":"FDA 510(k) K182971, SpaceOAR Vue Hydrogel, by Augmenix, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eHydrogel Spacer\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK182971\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e SpaceOAR Vue Hydrogel\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Augmenix, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e892.5725\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eOVB\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e10\/26\/2018\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 07\/19\/2019\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eRadiology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eRadiology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,586\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,291\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 295\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313220976804,"sku":"FDA510K182971","price":876.94,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k182971","provider":"FOIA Document Source","version":"1.0","type":"link"}