{"product_id":"fda-510k-k234027","title":"FDA 510(k) K234027, embecta Insulin Delivery System, by Embecta Medical I, LLC","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAlternate Controller Enabled Insulin Infusion Pump\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK234027\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e embecta Insulin Delivery System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Embecta Medical I, LLC\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.5730\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQFG\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e12\/20\/2023\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 08\/30\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 18,310\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 15,651\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 2,659\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334616228,"sku":"FDA510K234027","price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k234027","provider":"FOIA Document Source","version":"1.0","type":"link"}