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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
112-8865203-0/1/1 07-Sep-2012 78EZL 3003903031 Well Lead Medical Instruments China
 
BOS-0039167-5/1/1 18-Sep-2012 78FJK 3001451489 Fresenius Medical Care Holdings, Inc. United States
 
112-9446171-5/1/1 24-Sep-2012 78GBT 3009746297 Changzhou Yaping Medical China
 
AEK-0486157-7/1/1/B 07-Sep-2012 78LKY 3009722755 Lggjmy 4px China
 
AEK-0481573-0/1/1/B 12-Sep-2012 78LKY 3009444456 Cliff Bao Hong Kong SAR
 
AEK-0485500-9/1/1 14-Sep-2012 78LKY 3009721522 Kte/Co Yfhex China
 
AEK-0485498-6/1/1 14-Sep-2012 78LKY 3009721522 Kte/Co Yfhex China
 
AEK-0489268-9/1/1/B 18-Sep-2012 78LKY 3009722755 Lggjmy 4px China
 
112-8828790-2/2/2 14-Sep-2012 78MRE 3006217304 Contacare Ophthalmics & Diagnostics India
 
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