{"product_id":"fda-510k-k100662","title":"FDA 510(k) K100662, FEMVUE CORNUAL BALLOON CATHETER, by Femasys, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCannula, Manipulator\/Injector, Uterine\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK100662\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e FEMVUE CORNUAL BALLOON CATHETER\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Femasys, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e884.4530\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eLKF\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e03\/08\/2010\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 04\/07\/2010\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eObstetrics\/Gynecology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eObstetrics\/Gynecology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 105\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 14\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 91\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51310185742500,"sku":"FDA510K100662","price":341.3,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k100662","provider":"FOIA Document Source","version":"1.0","type":"link"}