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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
KG7-1012999-3/2/1 25-Nov-2008 78EYQ 3006981407 Fuhuida Imp & Exp Corp China
 
KG7-1012999-3/4/1 25-Nov-2008 78EYQ 3006981407 Fuhuida Imp & Exp Corp China
 
E84-0058192-0/1/1 25-Nov-2008 78FDF 1000080301 Pentax Medical Company United States
 
E84-0058192-0/1/2 25-Nov-2008 78FDS 1000080301 Pentax Medical Company United States
 
UPS-2583496-9/1/1/B 03-Nov-2008 78FHA 1000244108 Unknown China
 
UPS-2583496-9/1/1/A 03-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2641274-0/1/1/A 03-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2641046-2/1/1/B 03-Nov-2008 78FHA 3002807127 Guangzhou Guangxiang Enterprises Group Co., Ltd. China
 
UPS-2641046-2/1/1/C 03-Nov-2008 78FHA 1000244108 Unknown China
 
UPS-2640803-7/1/1/A 03-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2640803-7/1/1/B 03-Nov-2008 78FHA 1000244108 Unknown China
 
UPS-2640897-9/1/1/A 03-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2640897-9/1/1/B 03-Nov-2008 78FHA 1000244108 Unknown China
 
UPS-2651857-9/1/1/A 03-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2683344-0/1/1/A 12-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2640732-8/1/1/A 21-Nov-2008 78FHA 3007156919 G-Spot International Co., Ltd Taiwan
 
UPS-2640732-8/1/1/B 21-Nov-2008 78FHA 3007019454 H G V Canada
 
FR1-0012455-6/1/1 13-Nov-2008 78FJI 3000247873 Nipro Corporation Japan
 
FR1-0012472-1/2/1 21-Nov-2008 78FJI 3000247873 Nipro Corporation Japan
 
FR1-0012472-1/1/1 21-Nov-2008 78FKP 3000247873 Nipro Corporation Japan
 
UPS-1814697-0/2/1 17-Nov-2008 78KNT 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
112-4661386-6/1/1 03-Nov-2008 78KNW 1000263284 Carl Roth Gmbh & Co Kg Germany
 
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