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Summit Medical Products, inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17222141000117099Summit Medical Products, inc1Y2020-04-25504 West 8360 South Sandy UT US 84070

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1068611065256950K99136330 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDUFRN1999-05-13
1068611357658354K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpMEA2017-08-29
1068611989272467K110814AMBIT TUNNELERBSO2011-04-08
1068611980857242K102460AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATHBSO2011-01-13
1068611773460339K052221AMBIT PUSH & PLAY AMBULATORY INFUSION PUMPFRN2005-12-08
1068611455169108K033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMPFRN2003-11-06
1068611511208339K033325AMBIT CONTINUOUS AMBULATORY INFUSION PUMPFRN2003-11-06
1068611394553184K024190FENESTRATED INFUSION CATHETERFRN2003-03-17
1068611363357237K002434PALM PUMPMEA2000-08-23
1068611319585570K001287EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLKPE2000-06-09
1068611211229749
1068611445489263
1068611820121749
1068612001891222
1068612036816402

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN52005-12-08
MEA22017-08-29
BSO22011-04-08
KPE12000-06-09

PMN#