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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
310-8836592-4/1/1 31-Oct-2007 80BYY 1000115297 Parker Hannifin Corp, Medical Systems Division, Merrillville United States
 
FL2-0028105-1/6/1 04-Oct-2007 80FMZ 3004474927 Brittan Healthcare South Africa
 
FL2-0028105-1/4/1 04-Oct-2007 80FMZ 3004474927 Brittan Healthcare South Africa
 
EQ4-0007876-0/25/9 31-Oct-2007 80FQL 3004755469 I Ming Sanitary Materials Co Ltd Taiwan
 
510-7825863-2/51/1/D 18-Oct-2007 80FQM 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/E 18-Oct-2007 80FQM 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/F 18-Oct-2007 80FQM 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/G 18-Oct-2007 80FQM 3004209537 PHITEN CO., LTD. Japan
 
EJ7-0053035-8/17/1 22-Oct-2007 80FQM 3004073092 Ningbo Hooya Imp & Exp Co. Ltd. China
 
110-0503747-4/1/1 30-Oct-2007 80FQM 3005915667 Body Beautiful Canada Canada
 
EQ4-0007876-0/25/8 31-Oct-2007 80FQM 3004755469 I Ming Sanitary Materials Co Ltd Taiwan
 
EQ4-0007876-0/16/4 31-Oct-2007 80IKY 1000547756 Taiwan Stanch Co Ltd Taiwan
 
110-2912791-0/2/1 04-Oct-2007 80JOL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
KM6-0033807-3/17/1 23-Oct-2007 80KIA 3004329016 Mei Fung Medicine Co. China
 
EQ4-0007876-0/25/1 31-Oct-2007 80KMO 3004755469 I Ming Sanitary Materials Co Ltd Taiwan
 
EQ4-0007876-0/16/2 31-Oct-2007 80KYR 1000547756 Taiwan Stanch Co Ltd Taiwan
 
EQ4-0007876-0/16/5 31-Oct-2007 80KYS 1000547756 Taiwan Stanch Co Ltd Taiwan
 
224-4306750-3/43/1 04-Oct-2007 80LDQ 3000291935 K.K. Hakugen Japan
 
224-4306750-3/43/3 04-Oct-2007 80LDQ 3000291935 K.K. Hakugen Japan
 
224-4306750-3/43/2 04-Oct-2007 80LDQ 3000291935 K.K. Hakugen Japan
 
112-7174434-6/1/1 17-Oct-2007 80LDQ 3004716821 Excel Cherwell Site 2 United Kingdom
 
510-7825863-2/51/1/C 18-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/H 18-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/I 18-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/J 18-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/K 18-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
510-7825863-2/51/1/Q 19-Oct-2007 80LDQ 3004209537 PHITEN CO., LTD. Japan
 
EQ6-0006871-0/1/1 26-Oct-2007 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0006875-1/1/1 26-Oct-2007 80LDQ 5833 EPPENDORF AG Germany
 
ANP-0008415-3/435/1 26-Oct-2007 80LDQ 3005343641 Daison Industries Co Ltd Japan
 
EQ6-0006886-8/1/1 30-Oct-2007 80LDQ 5833 EPPENDORF AG Germany
 
112-8726346-3/1/1 31-Oct-2007 80LDQ 3004604967 ResMed Ltd. Australia
 
328-0507734-7/1/1 04-Oct-2007 80LYY 3003699698 Maxter Glove Manufacturing Sdn Bhd Malaysia
 
328-0507734-7/2/1 04-Oct-2007 80LYY 3003699698 Maxter Glove Manufacturing Sdn Bhd Malaysia
 
930-0211140-4/1/2 02-Oct-2007 80LYZ 3004135724 Shijiazhuang Holy Plastics Co., Ltd. China
 
DD2-2701337-0/1/1 15-Oct-2007 80MAJ 3006013685 Smiths Medical France Netherlands
 
FR1-0011955-6/1/1 01-Oct-2007 80MIA 3000247873 Nipro Corporation Japan
 
112-8178200-5/1/1 01-Oct-2007 80MMS 3005017924 Glycobiosciences Inc Canada
 
JF7-0058723-7/1/1 16-Oct-2007 80MTV 3006479675 Desarrollos Tecnicos Gtri Spain
 
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