{"product_id":"fda-510k-k141033-silverlon-antimicrobial-wound-contact-negative-pressure-dressings-silverlon-easy-ag-antimicrobial-wound-contact-negativ","title":"FDA 510(k) K141033, SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV, by Argentum Medical, LLC","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eSILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV\u003c\/strong\u003e (K141033), submitted by Argentum Medical, LLC.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K141033\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Negative Pressure Wound Therapy Powered Suction Pump\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Argentum Medical, LLC\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 04\/22\/2014\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 09\/12\/2014\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 878.478\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e OMP\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 611 (461 unredacted, 24% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e~ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 60% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 51% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 61% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 57% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 72% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 56% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 16% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 42% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 16% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454813798564,"sku":"FDA510K141033","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k141033-silverlon-antimicrobial-wound-contact-negative-pressure-dressings-silverlon-easy-ag-antimicrobial-wound-contact-negativ","provider":"FOIA Document Source","version":"1.0","type":"link"}