{"product_id":"fda-510k-k242473","title":"FDA 510(k) K242473, Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), by Coloplast Corp.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK242473\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Coloplast Corp.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e878.3300\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003ePAH\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e08\/20\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/18\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGeneral \u0026amp; Plastic Surgery\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 1,593\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,184\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 409\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334943908,"sku":"FDA510K242473","price":1108.4,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k242473","provider":"FOIA Document Source","version":"1.0","type":"link"}