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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-0269915-5/1/1 10-Feb-2006 78FFK 3002806910 Electro Medical Systems SA Switzerland
 
AEK-7081394-0/1/1 23-Feb-2006 78FHQ 3002914520 Solatch International Pakistan
 
FR1-0011402-9/3/1 08-Feb-2006 78FJI 3000247873 Nipro Corporation Japan
 
FR1-0011414-4/3/1 17-Feb-2006 78FJI 3000247873 Nipro Corporation Japan
 
004-9881271-8/2/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881271-8/3/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881271-8/5/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881271-8/7/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881271-8/9/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9892658-3/2/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9892697-1/1/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9892697-1/2/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9892697-1/4/1 03-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881229-6/2/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881229-6/3/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9881229-6/4/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9886692-0/2/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9886692-0/6/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9886692-0/4/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9878983-3/6/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9878983-3/2/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
004-9878983-3/4/1 07-Feb-2006 78KDI 3003490444 Gambro Dasco S.p.A. Monitor Division Italy
 
112-0391381-1/1/1 22-Feb-2006 78LIF 3004072823 Microcomponents Ltd. Switzerland
 
112-0352904-7/1/1 17-Feb-2006 78LRL 3005567680 Reto Braun Switzerland
 
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