FDA.reportPublic FDA data

KULZER, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18215141821514KULZER, LLC1Y2026-01-014315 S. Lafayette Blvd. SOUTH BEND IN US 46614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
217671826956995K992985GLUMA COMFORT BONDKLE1999-10-14
217671667377445K924024ORTHO WAXEGD1992-11-17
217671938367875K905058PALAVIT LEBH1991-06-06
217671627989830K812805STEELE'S ECON. PINK BASEPL. WAXES, I-IIIEGD1982-01-12
217671694403854K254063iCEM Universal PlusEMA2025-12-19
217671151283396
217671275582386
217671287542746
217671739272617
217672054734968
217671005912318
217671093986262
217671115505824
217671175321424
217671409901746
217671718360502
217671772234176
217671847773551
217671859035480

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EGD21992-11-17
EMA12025-12-19
KLE11999-10-14
EBH11991-06-06

PMN#