{"product_id":"fda-510k-k140667","title":"FDA 510(k) K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER, by Well Lead Medical Co., Ltd.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCatheter, Retention Type, Balloon\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK140667\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Well Lead Medical Co., Ltd.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.5130\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eEZL\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e03\/18\/2014\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 12\/15\/2014\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 447\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 276\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 171\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51310822326436,"sku":"FDA510K140667","price":616.54,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k140667","provider":"FOIA Document Source","version":"1.0","type":"link"}