【英语翻译WehavereviewedyourSection510(k)pre-marketnotificationofintenttomarketthedevicereferencedaboveandhavedeterminedthedeviceissubstantiallyequivalent(fortheindicationsforusestatedintheenclosure)tolegallymarke】

　　英语翻译

　　WehavereviewedyourSection510(k)pre-marketnotificationofintenttomarketthedevicereferencedaboveandhavedeterminedthedeviceissubstantiallyequivalent(fortheindicationsforusestatedintheenclosure)tolegallymarketedpredicatedeviceininterstatecommercepriortoMay28,1976,theenactmentdateoftheMedicalDeviceAmendments,ortodevicesthathavebeenreclassifiedinaccordancewiththeprovisionsoftheFederalFood,Drug,andCosmeticAct(Act)thatdonotrequireapprovalofapre-marketapprovalapplication(PMA).Youmay,thereforemarketthedevice,subjecttothegeneralcontrolsprovisionsoftheAct.ThegeneralcontrolsprovisionsoftheActincluderequirementsforannualregistration,listingofdevices,goodmanufacturingpractice,labeling,andprohibitionsagainstmisbrandingandadulteration.