FDA.reportPublic FDA data

Suzanne Danielson

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040518373004051837Suzanne Danielson1N2020-04-253M Center, 2510 Conway Ave. Bldg. 275-5W-06 Saint Paul MN US 55144
30068083923006808392Suzanne Danielson1N2020-04-253M Center, 2510 Conway Ave. Bldg. 275-5W-06 Saint Paul MN US 55144

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2347001087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
2347001172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
2347001424452243K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemOMP2018-06-01
2347001274760782K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02
2347001817889821K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemOMP2018-03-09
2347001244653294K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2017-01-26
2347101534856915K162508KerraCel Ag Gelling Fiber Silver DressingFRO2017-02-13
2347001141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
2347001586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
2347001497184851K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-PackOMP2016-02-29
2347001556321095K151710SNaP Wound Care SystemOKO2015-11-19
2347001181701807K142272SNaP Wound Care SystemOKO2014-11-25
2347002041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
2347002024830014K133137CISNAP CLOSED INCISION SYSTEMOKO2014-02-25
2347001804363628K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2013-11-15
2347001254910489K132080SNAP WOUND CARE SYSTEMOKO2014-03-12
2347001003651056K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGOMP2013-01-15
2347001116450263K123507KCI NPWT GAUZE DRESSINGOMP2013-04-04
2347001513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
2347001687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
2347001563462745K112341SNAP WOUND CARE SYSTEMOKO2011-08-29
2347001167757875K111393SNAP (R) WOUND CARE SYSTEMOKO2011-07-28
2347001482904268K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNITOMP2011-07-21
2347001337359578K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSINGOMP2010-12-15
2347001659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
2347001659207151K100657V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL UOMP2010-09-17
2347001512010664K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM DOMP2010-03-10
2347001607097090K083357OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510OMP2009-03-04
2347001160854755K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766OMP2007-06-07
2347001579094483K063692V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000OMP2007-06-07
2347001148127111K062227V.A.C. THERAPY SYSTEMOMP2006-10-04
2347001363938868DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsQFC2019-04-19
2347001336507508DEN080011SNAP WOUND CARE DEVICEOKO2009-08-07
2347001339244857
2347101388489355
2347101760487117
2347101801817907
2347101861204933
2347102057430558

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMP242019-03-20
OKO72015-11-19
QFC12019-04-19
FRO12017-02-13