FDA.reportPublic FDA data

CME AMERICA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069677103006967710CME AMERICA, LLC1N2020-04-2514998 W 6TH AVE STE 830 Golden CO US 80401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
898341290086963K080954T34L SYRINGE DRIVERFRN2008-05-16
898341733280905K042696BODYGUARD INFUSION PUMP SYSTEMFRN2005-03-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN22008-05-16