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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
FR1-0014942-1/1/1 08-Apr-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
FR1-0014958-7/1/1 10-Apr-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
112-2288498-9/1/1 25-Apr-2013 80BWJ 3010103012 Holidmed Germany Germany
 
MC2-6376653-7/1/1 17-Apr-2013 80BYY 3010098772 Zhejiang Haisheng Medical Device Co China
 
112-2133637-9/2/1 26-Apr-2013 80FLK 3009933346 Firbest Health Co China
 
EJ2-0109169-4/18/1 26-Apr-2013 80FLL 3009764393 Shenzhen Tomtop Technology Co. Ltd. China
 
FR1-0014896-9/2/1 08-Apr-2013 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014990-0/1/1 10-Apr-2013 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
004-6554085-4/1/1 29-Apr-2013 80FPO 3008158419 Shoshana Metal Works Israel
 
551-0524752-8/1/1 26-Apr-2013 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
551-0524752-8/2/1 26-Apr-2013 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
551-0524752-8/3/1 26-Apr-2013 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
551-0524752-8/4/1 26-Apr-2013 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
112-2315512-4/1/1 26-Apr-2013 80FRL 3006349398 Kettenbach Gmbh & Co Germany
 
112-2315512-4/1/3 26-Apr-2013 80FRL 1000317960 A. Kettenbach & Co. Gmbh Germany
 
E4K-0068098-8/1/1 05-Apr-2013 80KZH 3010018386 Yongkang City New View Industry & Trading Co., Ltd China
 
EQ6-0016468-3/1/1 12-Apr-2013 80LDQ 5833 EPPENDORF AG Germany
 
WC1-8540140-1/429/1 19-Apr-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546831-9/459/1 19-Apr-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
349-0941501-9/1/1 03-Apr-2013 80LYZ 3009648999 Tangshan Changrong Glove Co Ltd China
 
349-0941501-9/1/2 03-Apr-2013 80LYZ 3009648999 Tangshan Changrong Glove Co Ltd China
 
F23-9080877-2/1/1 08-Apr-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
ARV-0619840-7/1/1 15-Apr-2013 80LYZ 3003753496 Copious International, Inc. China
 
115-0083298-2/2/1 30-Apr-2013 80LYZ 3003340718 Shijiazhuang Eversharp Plastic Products Co., Ltd. China
 
WC1-8538802-0/386/1 19-Apr-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538821-0/223/1 19-Apr-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8543295-0/198/1 19-Apr-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8545125-7/177/1 19-Apr-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
FR1-0014952-0/1/1 03-Apr-2013 80MMK 3010044251 Sanipick Plastic Spain
 
FR1-0014975-1/1/1 10-Apr-2013 80MMK 3010044251 Sanipick Plastic Spain
 
FR1-0014976-9/1/1 10-Apr-2013 80MMK 3010044251 Sanipick Plastic Spain
 
BDN-0067727-3/1/2 15-Apr-2013 80MQX 3006618034 LAON CO, LTD Korea, Republic Of (South)
 
BDN-0067727-3/1/3 15-Apr-2013 80MQX 3006618034 LAON CO, LTD Korea, Republic Of (South)
 
BDN-0067727-3/1/4 15-Apr-2013 80MQX 3006618034 LAON CO, LTD Korea, Republic Of (South)
 
BDN-0067727-3/1/1 15-Apr-2013 80MQX 3006618034 LAON CO, LTD Korea, Republic Of (South)
 
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