{"product_id":"fda-510k-k180855","title":"FDA 510(k) K180855, Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, by Kci USA, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eNegative Pressure Wound Therapy Powered Suction Pump\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK180855\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Kci USA, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e878.4780\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eOMP\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e04\/02\/2018\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 06\/01\/2018\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\u003eGeneral \u0026amp; Plastic Surgery\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,567\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,422\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 145\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51310822883492,"sku":"FDA510K180855","price":509.85,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k180855","provider":"FOIA Document Source","version":"1.0","type":"link"}