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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
336-4240142-8/1/1 28-Aug-2003 78FKX 1000482435 Baxter Healthcare United States
 
AL6-0026093-2/1/1 15-Aug-2003 78KOG 6078 Aesculap Werk Aktiengesellschaft Germany
 
322-1504612-2/1/1 13-Aug-2003 78MOA 3002591507 Prostalund Operations AB Sweden
 
322-1504712-0/1/1 13-Aug-2003 78MOA 3002591507 Prostalund Operations AB Sweden
 
310-9108883-6/1/1 22-Aug-2003 78MRE 3003586878 Bioniche Therapuetics Canada
 
XXX-0065573-9/1/1 21-Aug-2003 78NHU 3003952657 Andro Medical Spain
 
XXX-0065565-5/1/1 29-Aug-2003 78NHU 3003952657 Andro Medical Spain
 
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