{"product_id":"fda-510k-k191057","title":"FDA 510(k) K191057, Park's Pectus System, by Tdm Co., Ltd.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003ePlate, Fixation, Bone\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK191057\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Park's Pectus System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Tdm Co., Ltd.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e888.3030\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eHRS\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e04\/22\/2019\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/19\/2020\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,198\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 887\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 311\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221042340,"sku":"FDA510K191057","price":909.48,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k191057","provider":"FOIA Document Source","version":"1.0","type":"link"}