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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 86-Ophthalmic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
K51-0056019-9/1/1 14-Jan-2005 86HKN 3004097705 Shin Nippon Commerce Inc Japan
 
K51-0056019-9/1/2 14-Jan-2005 86HLM 3004097705 Shin Nippon Commerce Inc Japan
 
APS-0100290-8/1/1 28-Jan-2005 86HLQ 3004897873 Nidek Col, Ltd Japan
 
AEK-7016060-7/1/1 18-Jan-2005 86HNI 3004921726 Yaza Surgical Industries Pakistan
 
322-1974076-1/1/1 21-Jan-2005 86HNR 3003348763 Cardiac Instruments Pakistan
 
112-5142117-8/1/1 04-Jan-2005 86HQD 1000241515 Ocular Sciences Limited United Kingdom
 
112-5155625-4/1/1 07-Jan-2005 86HQD 3003889710 Estafeta Mexicana Sa De Cv Mexico
 
112-5146526-6/1/1 04-Jan-2005 86HQF 1000629363 A.R.C. Laser Gmbh Germany
 
112-5344689-2/1/1 07-Jan-2005 86HQG 3003605540 Otimpor Ca Venezuela
 
112-5075758-0/1/1 04-Jan-2005 86HQY 3004835741 Optica Vision Colombia Colombia
 
R12-0029778-5/1/1 05-Jan-2005 86HQY 3003116697 Safilo Group S.p.A. Italy
 
256-0139092-2/3/1 14-Jan-2005 86HQY 3003661965 Bel Star S.A. Colombia
 
AVB-0806211-5/20/1 27-Jan-2005 86HQY 3004745198 Marni International S.A. Italy
 
EQ6-0003966-1/1/1 18-Jan-2005 86HQZ 3003347563 Wenzhou Import & Export United Corporation China
 
KX2-0015814-8/6/1 27-Jan-2005 86HQZ 3004483988 Wuyi Shengqi Motion Apparatus Co Ltd China
 
112-5045135-8/1/1 03-Jan-2005 86LPL 3003173210 Reel Eye Company Ltd The United Kingdom
 
112-5075867-9/1/1 04-Jan-2005 86LPL 1000658226 Wesley Jessen Corporation United States
 
112-5085927-9/1/1 06-Jan-2005 86LPL 3002082544 Ami United Kingdom
 
112-5064849-0/1/1 06-Jan-2005 86LPL 1000658226 Wesley Jessen Corporation United States
 
112-5063924-2/1/1 06-Jan-2005 86LPL 1118577 CooperVision, Inc. United States
 
112-5064844-1/1/1 06-Jan-2005 86LPL 1000115040 Ciba Vision Corporation United States
 
AEK-6652302-4/1/1 13-Jan-2005 86LPL 3003497071 Pt Vision Indonesia
 
112-5035886-8/1/1 28-Jan-2005 86MZD 3004176480 1866lens2go.Com Canada
 
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