FDA.reportPublic FDA data

EMMY MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103148363010314836EMMY MEDICAL, LLC1N2026-01-0184 Byron Rd Weston MA US 02493

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1805682052841637K181346CystoSure Plus CatheterEZL2018-08-06
1805681767025441K172422Kohli Urinary Drainage CatheterEZL2018-02-09
1805681156950806K142194CytoSure Urinary Access SystemFAJ2014-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZL22018-08-06
FAJ12014-12-19