FDA.reportPublic FDA data

OPTIK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17201291720129OPTIKEM INTERNATIONAL, INC.1N2020-04-252172 SOUTH JASON ST. Denver CO US 80223
30067383453006738345OPTIKHAN ARTISAN & CO.1N2020-04-25186 CHIMSANRO BUKGU DAEGU Daegu Gwangyeogsi KR 702-858

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
803981418272511P870051
803981309318632P870050
803982002683786K071203SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSESLPN2007-06-13
803981226366919K011561SEREINE EXTRA STRENGTH DAILY CLEANERLPN2001-11-20
679671721240799
679672069692765

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPN22007-06-13

PMN#