{"product_id":"fda-510k-k181642","title":"FDA 510(k) K181642, B-Laser Atherectomy System, by Eximo Medical, Ltd.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCatheter, Peripheral, Atherectomy\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK181642\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e B-Laser Atherectomy System\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Eximo Medical, Ltd.\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.4875\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eMCW\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e06\/21\/2018\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/05\/2018\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,851\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e \u003cmeta charset=\"utf-8\"\u003e2,560\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e \u003cmeta charset=\"utf-8\"\u003e291\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313220845732,"sku":"FDA510K181642","price":669.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k181642","provider":"FOIA Document Source","version":"1.0","type":"link"}