{"product_id":"fda-510k-k250555","title":"FDA 510(k) K250555, MallyaD injection pen adapter (MallyaD), by Biocorp Production","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eInjection Data Capture Device\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK250555\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e MallyaD injection pen adapter (MallyaD)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Biocorp Production\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.5860\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQOG\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e02\/25\/2025\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/27\/2025\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 254\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 171\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 83\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313337958564,"sku":"FDA510K250555","price":314.26,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k250555","provider":"FOIA Document Source","version":"1.0","type":"link"}