FDA.reportPublic FDA data

Stefanie Koenig

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30149450503014945050Stefanie Koenig1N2020-04-25315 Shawnee North Dr. Suite 100 Suwanee GA US 30024

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2270661480546458K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection SetFMI2018-12-03
2270661857960770K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKA2017-05-19
2270661487334798K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleMEG2016-08-19
2270661549638496K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
2270661544461292K152597ProteXsure Safety Capsule SystemFMI2016-06-08
2270661058563390K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEG2014-05-22
2270661913550536K123684SOL-CARE SAFETY NEEDLEFMI2013-05-08
2270661256365021K112777SOL-M EXCHANGEABLE NEEDLESFMI2012-02-24
2270661689414423K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)FMF2010-08-20
2270661108018373K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGESMEG2009-09-04
2270661087451884K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESMEG2009-09-04
2270661221764143K063334SHANGHAI GANGHAI MODEL GIKO 1400MSH2006-12-08
2270661086066174
2270661430997487
2270661498827235
2270661810365395

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI42018-12-03
MEG42016-08-19
FMF22016-06-17
JKA12017-05-19
MSH12006-12-08