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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
K51-0065304-4/1/1 14-Oct-2008 78EZN 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065298-8/1/1 31-Oct-2008 78EZN 3004968149 Rz Medizintech Gmbh Germany
 
508-0315508-9/1/1 28-Oct-2008 78EZQ 3006417681 Convatec Dominican Republic Dominican Republic
 
K51-0065299-6/1/3 14-Oct-2008 78FAJ 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065299-6/1/1 14-Oct-2008 78FBQ 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065299-6/1/2 14-Oct-2008 78FCL 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065304-4/1/2 14-Oct-2008 78FFL 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065298-8/1/2 31-Oct-2008 78FFL 3004968149 Rz Medizintech Gmbh Germany
 
K51-0065299-6/1/5 14-Oct-2008 78FFN 3004968149 Rz Medizintech Gmbh Germany
 
FR1-0012433-3/2/1 20-Oct-2008 78FJI 3000247873 Nipro Corporation Japan
 
FR1-0012392-1/1/1 20-Oct-2008 78FJI 3000247873 Nipro Corporation Japan
 
K51-0065299-6/1/6 14-Oct-2008 78FJL 3004968149 Rz Medizintech Gmbh Germany
 
AEK-9978583-0/1/2 10-Oct-2008 78GCP 3007133829 Creaciones Anysa Sl Spain
 
AEK-9978583-0/1/1 10-Oct-2008 78GCP 3007133829 Creaciones Anysa Sl Spain
 
XXX-0156198-5/3/1 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156198-5/3/2 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156198-5/3/3 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156198-5/3/4 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156198-5/3/5 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/1 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/2 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/3 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/4 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/5 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/6 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/7 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/8 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156218-1/1/9 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/1 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/2 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/3 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/4 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/5 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/6 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/7 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/8 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/9 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/10 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/11 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
XXX-0156238-9/2/12 29-Oct-2008 78LKY 3006759767 Innovatech Designs Canada
 
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