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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
T94-0034018-6/2/1 17-Mar-2004 80BRZ 3003205539 Poly Medicure Limited India
 
AEK-6349018-5/1/1/B 31-Mar-2004 80FMI 3004104361 New Garrison Surgical Works Pakistan
 
MH9-0029880-2/1/1 09-Mar-2004 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0030317-2/1/1 23-Mar-2004 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
AEK-6332781-7/2/1 04-Mar-2004 80FOR 3004453112 Darryl Speer Canada
 
T94-0034018-6/6/1 17-Mar-2004 80FOZ 3003205539 Poly Medicure Limited India
 
T94-0034018-6/7/1 17-Mar-2004 80FPK 3003205539 Poly Medicure Limited India
 
AEK-6332781-7/1/1 04-Mar-2004 80KGX 3004453112 Darryl Speer Canada
 
T94-0034018-6/4/1 17-Mar-2004 80KZD 3003205539 Poly Medicure Limited India
 
AEK-6335858-0/2/1 10-Mar-2004 80KZE 1000194876 Syndell Laboratories Canada
 
EE6-2009515-2/18/2 31-Mar-2004 80KZH 3004485664 Shanghai Dway International Hong Kong SAR
 
582-7213333-1/1/1 17-Mar-2004 80LDQ 3004121692 Kujira Co Ltd Japan
 
NA4-4004713-5/2/1 18-Mar-2004 80LDQ 3002879284 Innomed Medical Inc Hungary
 
EQ6-0003285-6/1/1 18-Mar-2004 80LDQ 5833 EPPENDORF AG Germany
 
AEK-6009515-1/1/1 19-Mar-2004 80LDQ 3001451326 CryoLife, Inc. United States
 
199-0035543-9/1/1 11-Mar-2004 80LYY 3004129254 Motex International Corp. Taiwan
 
101-6526859-9/1/1 03-Mar-2004 80LYZ 3003005465 Shanghai Jiawang Industrial Co., Ltd. China
 
484-2007921-1/2/1/A 10-Mar-2004 80LYZ 3002751308 Long First (Xiamen) Plastics Co., Ltd. China
 
EE6-2009515-2/2/4 31-Mar-2004 80MIO 3004485664 Shanghai Dway International Hong Kong SAR
 
T94-0034018-6/1/1 17-Mar-2004 80MRZ 3003205539 Poly Medicure Limited India
 
112-2897716-1/1/1 30-Mar-2004 80MWV 3002537242 Cot Int Netherlands
 
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