{"product_id":"fda-510k-k130690","title":"FDA 510(k) K130690, Z-800 INFUSION SYSTEM, by Zyno Medical, LLC","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003ePump, Infusion\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK130690\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Z-800 INFUSION SYSTEM\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Zyno Medical, LLC\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.5725\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eFRN\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e03\/14\/2013\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 06\/12\/2013\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,112\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 15\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 1,097\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308059263140,"sku":"FDA510K130690","price":2502.6,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k130690","provider":"FOIA Document Source","version":"1.0","type":"link"}