{"product_id":"fda-510k-k211318","title":"FDA 510(k) K211318, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs, by Smith Nephew Medical Limited","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\u003eK211318\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Smith Nephew Medical Limited\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\/30\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 01\/05\/2022\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 2,084\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,462\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 622\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221402788,"sku":"FDA510K211318","price":1540.58,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k211318","provider":"FOIA Document Source","version":"1.0","type":"link"}