{"product_id":"fda-510k-k131817","title":"FDA 510(k) K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, by Osmunda Medical Device Consulting Co., Ltd.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eLithotriptor, Extracorporeal Shock-Wave, Urological\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK131817\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Osmunda Medical Device Consulting Co., Ltd.\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.599\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eLNS\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e06\/20\/2013\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 09\/26\/2014\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,489\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,053\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 436\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308063031460,"sku":"FDA510K131817","price":1162.65,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k131817","provider":"FOIA Document Source","version":"1.0","type":"link"}